chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Congenital anomaly, Immunisation, Maternal exposure during pregnancy
Clinical narrative: Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'; Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), transplacental, administration date 08Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 31 years old at the time of vaccination. The mother's relevant medical history included: "Hypothyroid" (unspecified if ongoing). Date of last menstrual period of the mother: 25Oct2021. The mother was 6 weeks pregnant at the event onset. The mother is expected to deliver a baby(s) on 01Aug2022. The mother's concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose 1, Lot number unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, Lot number unknown). The mother did not have COVID prior to vaccination. The mother was not Covid test post vaccination. The mother had no known allergies.  The following information was reported: IMMUNISATION (death, congenital anomaly) with onset 08Dec2021, outcome "fatal", described as "booster"; CONGENITAL ANOMALY (death, congenital anomaly), MATERNAL EXPOSURE DURING PREGNANCY (death, congenital anomaly) all with onset 11Dec2021, outcome "fatal" and all described as "Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'". The pregnancy resulted in spontaneous abortion. The fetal outcome is congenital anomaly. The patient date of death was unknown. The reported cause of death was congenital anomaly. 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: Linked Report(s) : US-PFIZER INC-202200007639 mother case; Reported Cause(s) of Death: Miscarriage./seriousness criterion was reported as 'Congenital anomaly/birth defect'
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a literature report. This study involved 179 individuals aged 12 to 18 years hospitalized for laboratory-confirmed COVID-19 and a control group of 285 adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a literature report for the following literature source(s)  This study involved  individuals aged hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: vaccination failure (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a literature report for the following literature source(s).  This study involved individuals aged hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: vaccination failure (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a literature report for the following literature source.  This study involved individuals  hospitalized for laboratory-confirmed COVID-19 and a control group of adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded, Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a literature report.  This study involved 179 individuals aged 12 to 18 years hospitalized for laboratory-confirmed COVID-19 and a control group of 285 adolescents hospitalized for other causes between June and September 2021. Six vaccinated patients were hospitalized for COVID-19, and none were admitted to the intensive care unit (ICU) or died. It excluded partially vaccinated individuals. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: laboratory-confirmed COVID-19: (2021) positive.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202101695462 Same article/ drug/event and different patient
Sex: U
Vaccine: COVID19
Symptoms: Chills, Drug ineffective, Headache, Immunisation, Myalgia
Clinical narrative: booster; I think I have Covid; I think I have Covid; headaches; chills; muscle soreness; 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 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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I think I have Covid"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown", described as "chills"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness".  Clinical course: Patient took both Pfizer shots and the booster. Patient think that have Covid and patient currently waiting in a line over a hour long for rapid testing. Patient had headaches, chills, muscle soreness. Patient breathing has been alright.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: booster; I think I have Covid; I think I have Covid; headaches; chills; muscle soreness; 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 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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I think I have Covid"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown", described as "chills"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness".  Clinical course: Patient took both Pfizer shots and the booster. Patient think that have Covid and patient currently waiting in a line over a hour long for rapid testing. Patient had headaches, chills, muscle soreness. Patient breathing has been alright.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Positive; Covid Positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 28May2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single and intramuscular, administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Lot unknown reason: Not available/provided to reporter at the time of report completion The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies and other medical history was unknown. Other vaccine in four weeks was reported as no and unknown if patient received other medications in two weeks. covid prior vaccination: No and covid tested post vaccination: Yes. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "not recovered" and all described as "Covid Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Myocardial infarction, Pain, Thrombosis
Clinical narrative: blood clot in rt pinky; felt like a heart attack; Pain for several weeks; didnt bleed when I cut myself shaving/ Blood still thick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0162) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low level asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydromet cough syrup, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 12Mar2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 25May2021, outcome "unknown", described as "blood clot in rt pinky"; MYOCARDIAL INFARCTION (medically significant) with onset 25May2021, outcome "unknown", described as "felt like a heart attack"; PAIN (non-serious) with onset 25May2021, outcome "recovered" (2021), described as "Pain for several weeks"; BLOOD DISORDER (non-serious) with onset 25May2021, outcome "unknown", described as "didnt bleed when I cut myself shaving/ Blood still thick". The events "blood clot in rt pinky", "felt like a heart attack", "pain for several weeks" and "didnt bleed when i cut myself shaving/ blood still thick" were evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombosis, myocardial infarction, pain, blood disorder. Addition information: it was reported that: believe clot eventually traveled to rt side of arm (june) to left side of neck (July 22) to left side of chest (23Jul2021), felt like heart attack. Covid prior vaccination was none. Covid tested post vaccination was none. Other vaccine in four weeks was none. Other medication in two weeks was none. Pain dimished within week. When it got to neck. Took aspirin 2 daily then one.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: Booster; COVID-19; COVID-19; 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: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Clinical course: The patient had both vaccines and the booster, all Pfizer, and stated, "why am I in the country with COVID being treated like a 2nd class citizen I will not promote your vaccine any longer. I have been a study voice for your product".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: EW0172) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "All nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: ER8737), administration date: 02Apr2021, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient got covid with the following symptoms: cough, sore throat, fatigue, stuffy nose. There was no prolonged hospitalization. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive Covid-19 virus; Tested positive Covid-19 virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EP7533) at the age of 52 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" (03Jan2022) and all described as "Tested positive Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative; (26Dec2021) positive. Patient tested positive for the Covid virus on the Day after Christmas 26Dec2021, quarantined then for 10 days, tested negative on 03Jan2022, wants to know when is the soonest time to get the booster. It was unknown if other products were administered or not. Investigation assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Immunisation, Loss of consciousness, Visual impairment
Clinical narrative: BNT162B2 DOSE 3 (BOOSTER); Passed out; drenched in sweat; half vision; This is a spontaneous report received from a non-contactable consumer.  A 17 year-old 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 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "BNT162B2 DOSE 3 (BOOSTER)"; LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "Passed out"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "drenched in sweat"; VISUAL IMPAIRMENT (non-serious), outcome "recovering", described as "half vision". Additional information: The patient got her booster Wednesday at 2 and got up Thursday am around 10:30 and passed out. The patient was drenched in sweat with half vision. She's seeming better now, had some gingerale and crackers and is laying with me in bed. No other issues, seeing normally now, no chest/breathing issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise, Rash macular, Scleroderma
Clinical narrative: scleroderma; lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs; feel unwell; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (I was forced to be vaccinated with 1 dose of Pfizer coronavirus vaccination. I didn't feel any negative reactions.), administration date: 13Sep2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RASH MACULAR (non-serious) with onset 18Oct2021, outcome "unknown", described as "lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs"; MALAISE (non-serious) with onset 18Oct2021, outcome "unknown", described as "feel unwell"; DIZZINESS (non-serious) with onset 18Oct2021, outcome "unknown", described as "dizziness"; ASTHENIA (non-serious) with onset 18Oct2021, outcome "unknown", described as "weakness". The events "scleroderma", "lilac and bright red spots of 0.5 centimeters- 7 centimeters appeared in the abdomen, under the arms, and between the legs", "feel unwell", "dizziness" and "weakness" were evaluated at the physician office visit. Addition information: It was reported that: I went to the doctors and was diagnosed with Scleroderma. I am sure that the immediate development of this dangerous disease was provoked by the Pfizer Covid19 vaccine. I am ready to undergo an examination to clarify the disease caused by the Pfizer Covid19 vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive.; Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive.; Booster; This is a spontaneous report received from a contactable reporter (consumer).  A 40-year-old male patient received BNT162B2 (COMIRNATY), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (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: IMMUNISATION (medically significant) with onset Dec2021, described as "Booster"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "Developed a brief headache/ Tested negative with a rapid antigen test. PCR came back the following day positive." The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: positive and negative. Clinical course: The patient was fully vaccinated with COMIRNATY and received a booster dose, and in less than 24 hours, he developed a brief headache on 26Dec2021. He then tested negative for COVID-19 with rapid antigen test and his PCR test came back positive the following day. The remainder of his family was tested of which all members were fully vaccinated and were all asymptomatic. Of the remaining 4 family members tested, all were antigen negative. At the time of the report, PCR results were available for 3 of the 4 family members of which one was positive (fully vaccinated with COMIRNATY- 10-years-old) and 2 negative (10-years and 8-years-old).  The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200009294 same reporter and drug, similar events, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: one was positive (fully vaccinated w Comirnaty - 10 y ); one was positive (fully vaccinated w Comirnaty - 10 y ); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old patient received bnt162b2 (COMIRNATY) (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 "one was positive (fully vaccinated w Comirnaty - 10 y )". 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.; Sender's Comments: Linked Report(s) : PFIZER INC-202200009245 Same reporter/drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough COVID illness; Breakthrough COVID illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single. 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) all with onset 03Jan2022, outcome "not recovered" and all described as "Breakthrough COVID illness". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms; tested positive for COVID-19 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (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 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Event took place after the use of the product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus.; received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 03Mar2021 13:15 (Lot number: EN6205) at the age of 24 years as dose 2, single and intramuscular, administration date 03Jan2021 (Lot number: EH9899) as dose 1, single, administered in deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Measles, mumps, and rubella vaccines, for Immunization, reaction(s): "never got those diseases". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Dec2021, outcome "unknown", described as "received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus."; COVID-19 (medically significant) with onset 30Dec2021, outcome "unknown", described as "received 2 doses of the Pfizer BioNTech Covid-19 vaccine and has tested positive for the Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Tested with an at-home kit and was positive; (03Jan2022) positive, notes: Officially tested positive at a doctors office. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Patient is a registered nurse who received 2 doses of the Pfizer BioNTech Covid-19 vaccine and was tested positive for the Covid-19 virus. Patient did not receive any additional vaccines on the same date as that of Pfizer suspect. Patient received no other vaccines within 4 weeks prior to the first administration of suspect COVID-19 vaccine. Patient experienced no adverse events with prior vaccines. Patient reported that the vaccine did not do what it was intended to do. Patient still got COVID and spread it to everyone in his house and his family is sick and that two other people in his house have received medical treatment and intervention. Patient reported that the two other people in his house were vaccinated and tested positive for COVID-19. They were his mom and step-dad. The patient reported that they are sick and not doing well. Patient reported that he infected his whole family. Patient reported it is serious as patient works with geriatric patients. Patient reported that the COVID-19 Vaccine is the only vaccine he had that didn't work. Patient did not visit the emergency room or physician office due to adverse event.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: a lot of pain in legs; he might had a blood clot; Numbness in leg; Arthritis/ arthritis in both legs; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-3920316-00 (Agency).  A 84 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "a lot of pain in legs"; THROMBOSIS (medically significant), outcome "unknown", described as "he might had a blood clot"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in leg"; ARTHRITIS (non-serious), outcome "not recovered", described as "Arthritis/ arthritis in both legs "; FATIGUE (non-serious), outcome "recovering", described as "Fatigue". The patient was hospitalized for pain in extremity (hospitalization duration: 3 day(s)). The events "a lot of pain in legs" and "numbness in leg" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: laboratory test: unknown results, notes: could not find out the cause or what was wrong. Therapeutic measures were taken as a result of pain in extremity. On 28Dec2021, he had to use pain killers over the counter to alleviate pain in left leg. The pain alternated. He had a walker and cane.   Causality for Humira with events (arthritis, fatigue, numbness in leg) per reporter was reported as reasonable possibility. The reporter considered "fatigue" not related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported fatigue and suspect drug BNT162B2  Based on the information currently available,The casual association between the reported other events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a lot of pain in legs; he might had a blood clot; Numbness in leg; Arthritis/ arthritis in both legs; Fatigue; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 21K-163-3920316-00 (Agency).  A 84 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (hospitalization), outcome "unknown", described as "a lot of pain in legs"; THROMBOSIS (medically significant), outcome "unknown", described as "he might had a blood clot"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness in leg"; ARTHRITIS (non-serious), outcome "not recovered", described as "Arthritis/ arthritis in both legs "; FATIGUE (non-serious), outcome "recovering", described as "Fatigue". The patient was hospitalized for pain in extremity (hospitalization duration: 3 day(s)). The events "a lot of pain in legs" and "numbness in leg" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: laboratory test: unknown results, notes: could not find out the cause or what was wrong. Therapeutic measures were taken as a result of pain in extremity. On 28Dec2021, he had to use pain killers over the counter to alleviate pain in left leg. The pain alternated. He had a walker and cane.   Causality for Humira with events (arthritis, fatigue, numbness in leg) per reporter was reported as reasonable possibility. The reporter considered "fatigue" not related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported fatigue and suspect drug BNT162B2  Based on the information currently available,The casual association between the reported other events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Hypersensitivity, Myocardial injury, Myocardial necrosis marker
Clinical narrative: almost died as a result of getting the Pfizer vaccine; The patient had a severe allergic reaction; blood pressure to severely drop and at 1 point was 73/35.; heart damage; cardiac enzymes to increase; 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 63-year-old patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (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: NEAR DEATH EXPERIENCE (hospitalization, medically significant, life threatening), outcome "unknown", described as "almost died as a result of getting the Pfizer vaccine"; HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "The patient had a severe allergic reaction"; BLOOD PRESSURE DECREASED (hospitalization), outcome "unknown", described as "blood pressure to severely drop and at 1 point was 73/35."; MYOCARDIAL INJURY (hospitalization), outcome "unknown", described as "heart damage"; MYOCARDIAL NECROSIS MARKER INCREASED (hospitalization), outcome "unknown", described as "cardiac enzymes to increase". The patient was hospitalized for near death experience, hypersensitivity, blood pressure decreased, myocardial necrosis marker increased (hospitalization duration: 5 day(s)); the patient was hospitalized for myocardial injury (hospitalization duration: 5 day(s)). The events "almost died as a result of getting the pfizer vaccine", "the patient had a severe allergic reaction", "blood pressure to severely drop and at 1 point was 73/35.", "heart damage" and "cardiac enzymes to increase" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 73/35; myocardial necrosis marker: increased. The patient had a severe allergic reaction and almost died as a result of getting the Pfizer vaccine. The Pfizer shot caused the patient's blood pressure to severely drop and at 1 point was 73/35. The patient's doctor's office had to call and the patient was admitted to the hospital for 5 days. Turned out, the Pfizer shot had caused heart damage and the patient had to have a cardiac cath. The vaccine also caused cardiac enzymes to increase. The patient almost died.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial necrosis marker increased, Near death experience
Clinical narrative: almost died as a result of getting the Pfizer vaccine; The patient had a severe allergic reaction; blood pressure to severely drop and at 1 point was 73/35.; heart damage; cardiac enzymes to increase; 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 63-year-old patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (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: NEAR DEATH EXPERIENCE (hospitalization, medically significant, life threatening), outcome "unknown", described as "almost died as a result of getting the Pfizer vaccine"; HYPERSENSITIVITY (hospitalization), outcome "unknown", described as "The patient had a severe allergic reaction"; BLOOD PRESSURE DECREASED (hospitalization), outcome "unknown", described as "blood pressure to severely drop and at 1 point was 73/35."; MYOCARDIAL INJURY (hospitalization), outcome "unknown", described as "heart damage"; MYOCARDIAL NECROSIS MARKER INCREASED (hospitalization), outcome "unknown", described as "cardiac enzymes to increase". The patient was hospitalized for near death experience, hypersensitivity, blood pressure decreased, myocardial necrosis marker increased (hospitalization duration: 5 day(s)); the patient was hospitalized for myocardial injury (hospitalization duration: 5 day(s)). The events "almost died as a result of getting the pfizer vaccine", "the patient had a severe allergic reaction", "blood pressure to severely drop and at 1 point was 73/35.", "heart damage" and "cardiac enzymes to increase" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 73/35; myocardial necrosis marker: increased. The patient had a severe allergic reaction and almost died as a result of getting the Pfizer vaccine. The Pfizer shot caused the patient's blood pressure to severely drop and at 1 point was 73/35. The patient's doctor's office had to call and the patient was admitted to the hospital for 5 days. Turned out, the Pfizer shot had caused heart damage and the patient had to have a cardiac cath. The vaccine also caused cardiac enzymes to increase. The patient almost died.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Cough, Drug ineffective
Clinical narrative: COVID Positive; Drug ineffective; sweating; Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 14:00 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administered in arm right, administration date 12Apr2021 09:00 (Lot number: EP6955) as dose 2, single and administered in arm right, administration date 22Mar2021 09:00 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dairy allergy" (unspecified if ongoing), notes: other medical history: dairy allergy; "known allergy: Penicillin" (unspecified if ongoing), notes: known allergy: Penicillin. Concomitant medication(s) included: LISINOPRIL; HCTZ; OMEPRAZOLE; FLONASE; ALLEGRA. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021 02:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 02Jan2022, outcome "unknown" and all described as "Positive"; HYPERHIDROSIS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sweating"; COUGH (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "Cough"; RHINORRHOEA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "congestion"; CHILLS (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 31Dec2021 14:00, outcome "recovering", described as "fever (up to 101.7)". The patient underwent the following laboratory tests and procedures: body temperature: (31Dec2021) 101.7, notes: adverse event: Cough; runny nose; sore throat; congestion; chills; fever (up to 101.7); sweating; sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of immunisation, hyperhidrosis, cough, rhinorrhoea, oropharyngeal pain, nasal congestion, chills, pyrexia.  Additional information:no other vaccine in four weeks,no COVID prior vaccination, COVID tested post vaccination  No follow-up attempts are possible. No further information is expected.