chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Granulomatosis with polyangiitis, Respiratory failure
Clinical narrative: wegener's granulomatosis or granulomatous with polyangiitis; acute kidney failure; respiratory failure; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 79 years as dose 2 (booster), single for covid-19 immunisation. The patient's concomitant medications were not reported. Vaccination history included: Johnson and Johnson vaccine (1st dose), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: GRANULOMATOSIS WITH POLYANGIITIS (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "wegener's granulomatosis or granulomatous with polyangiitis"; ACUTE KIDNEY INJURY (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "acute kidney failure"; RESPIRATORY FAILURE (hospitalization, medically significant, life threatening) with onset 26Dec2021, outcome "not recovered", described as "respiratory failure". The patient was hospitalized for granulomatosis with polyangiitis, acute kidney injury, respiratory failure (hospitalization duration: 10 day(s)). The events "wegener's granulomatosis or granulomatous with polyangiitis", "acute kidney failure" and "respiratory failure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: covid-19: (08Feb2022) negative, notes: Nasal swab. Therapeutic measures were taken as a result of granulomatosis with polyangiitis, acute kidney injury, respiratory failure (IV steroids, hemodialysis and may need a biologic). The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Sciatica
Clinical narrative: Bad chills; Muscle aches; After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 39 years as dose 1, single and the patient also received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sciatica"  (unspecified if ongoing). The patient did not received any concomitant medications. The following information was reported: CHILLS (non-serious) with onset 24Jan2022, outcome "recovering", described as "Bad chills"; MYALGIA (non-serious) with onset 24Jan2022, outcome "recovering", described as "Muscle aches"; SCIATICA (non-serious) with onset 24Jan2022, outcome "recovering", described as "After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom". The events "Bad chills", "Muscle aches" and "After taking the 1st dose I experienced such bad chills, muscle aches that it triggered my sciatica it was had for me to move, get out of bed, bend or use the bathroom" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, myalgia and sciatica.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Treatment for the reported events included muscle relaxers and anti-inflammatory medications. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Throat tightness, Tinnitus, Wheezing
Clinical narrative: The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine; This is a literature report for the following literature source.  A 55 year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "DMII" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: Patient presented to the allergy clinic after the rare reaction to her first shot of the Pfizer-BioNtech mRNA vaccine. Patient developed, THROAT TIGHTNESS (hospitalization), WHEEZING (hospitalization), HEADACHE (hospitalization), outcome "recovering" and all described as "The patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the SARS COV2 Pfizer vaccine"; TINNITUS (hospitalization), outcome "not recovered". The event "the patient developed, throat fullness, wheezing, tinnitus, severe headache 5 minutes after receiving her first injection of the sars cov2 pfizer vaccine", was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: no abnormalities found. She was treated with epinephrine in ER and was admitted for extensive workup and special consultations. No significant abnormalities were found and while she improved clinically, her tinnitus has persisted for months despite treatments with corticosteroids, levetiracetam and antibiotics. Therapeutic measures were taken as a result of throat tightness, wheezing, tinnitus, headache.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the available information in the case, the causal association between the event throat tightness, wheezing, tinnitus, headache and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diffuse alopecia, SARS-CoV-2 test
Clinical narrative: Telogen effluvium hair loss; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16May2021 at 12:00 (Lot number: EW0168) at the age of 25 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EP7534; Anatomical location: Left arm; Administration time: 11:00), administration date: 25Apr2021, when the patient was 24 years old, for COVID-19 immunisation.  The following information was reported: DIFFUSE ALOPECIA (non-serious) with onset 01Aug2021 at 15:00, outcome "not recovered", described as "Telogen effluvium hair loss". The event "Telogen effluvium hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of diffuse alopecia.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Inappropriate schedule of product administration
Clinical narrative: Appendicitis; Prev dose administration date=26Mar2021, Prev dose dose number=1/ Administration date=02Apr2021, Dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200291865 (Pfizer).  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 14:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRINTELLIX. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Mar2021, when the patient was 26 years old, for COVID-19 Immunization. The patient was reporting about Covid vaccine for AE. Facility type vaccine was reported as, other. No other vaccine was administered in four weeks. The following information was reported: APPENDICITIS (hospitalization, life threatening) with onset 03Apr2021 00:45, outcome "recovered", described as "Appendicitis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 14:00, outcome "unknown", described as "Prev dose administration date=26Mar2021, Prev dose dose number=1/ Administration date=02Apr2021, Dose number=2". The patient was hospitalized for appendicitis (hospitalization duration: 1 day(s)). The event "appendicitis" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of appendicitis. Appendicitis, resulted in the Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). AE treatment was mentioned as, Appendectomy. Patient had no covid prior vaccination and it was unknown if covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Why did my family get covid? We've all had vax + booster. Your shots don't work.; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Why did my family get covid? We've all had vax + booster. Your shots don't work."; COVID-19 (medically significant), outcome "unknown", described as "COVID-19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Costochondritis, Investigation, X-ray
Clinical narrative: chest pains worsened; chest pains worsened; costochondritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (003110). The reporter is the parent.  A 19 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jan2021 (unspecified if ongoing), notes: COVID; "mild chest pains", start date: Jan2021 (ongoing), notes: mild chest pains. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "chest pains worsened"; COSTOCHONDRITIS (non-serious) with onset 2021, outcome "unknown", described as "costochondritis". The events "chest pains worsened", "chest pains worsened" and "costochondritis" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My 19 year old daughter had mild chest pains when she had Covid in Jan2021. When she received the first Pfizer vaccine, her chest pains worsened and it has not gotten better today. The doctors say it's costochondritis. We have tried everything and she has taken several tests and x-rays. Nothing is helping her and these chest pains are preventing her from participating in her sport at college. Do you have any data on this matter and how to treat. We don't know how to remedy this. Please help  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pruritus
Clinical narrative: Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021; nocturnal severe itching of palms, hands, and soles of the feet; elbow and joint pain; severe burning and itching at the palms of her hand, soles of her feet that lasted for months; have affected her activities of daily living; allergic reaction; especially in her elbows keep her from sleeping; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Jan2021 (unspecified if ongoing), notes: her joints were so sore, especially her elbows. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, around middle of Sep2021, Route, Anatomical Location: arm), administration date: Sep2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset Sep2021, outcome "unknown", described as "Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021"; PRURITUS (medically significant) with onset 2021, outcome "recovering", described as "nocturnal severe itching of palms, hands, and soles of the feet"; ARTHRALGIA (medically significant) with onset 2021, outcome "recovering", described as "elbow and joint pain"; BURNING SENSATION (medically significant) with onset 2021, outcome "recovering", described as "severe burning and itching at the palms of her hand, soles of her feet that lasted for months"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 2021, outcome "recovering", described as "have affected her activities of daily living"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "especially in her elbows keep her from sleeping". Therapeutic measures were taken as a result of pruritus, arthralgia, burning sensation, loss of personal independence in daily activities, hypersensitivity, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. 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: Cardiac disorder, Cardiac failure, Chronic obstructive pulmonary disease, Lung neoplasm malignant, Neoplasm malignant
Clinical narrative: Right side heart failure (which he has been hospitalized before); Has low indicators of heart disease (no cholesterol and no triglycerides); heart failure was associated with his COPD; 2 types of cancer; on of the being lung cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 02Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 02), administration date: Jan2021, for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "2 types of cancer"; LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "on of the being lung cancer"; CARDIAC FAILURE (hospitalization), outcome "unknown", described as "Right side heart failure (which he has been hospitalized before)"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has low indicators of heart disease (no cholesterol and no triglycerides)"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "heart failure was associated with his COPD". The patient underwent the following laboratory tests and procedures: total lung capacity: 65 %, notes: COPD with a lung capacity of 65%.  Clinical Course: The patient had comorbidities. He was aware that the efficacy of the vaccine wanes after 6 months and wished to get information on if he would be able to get a second booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Total lung capacity
Clinical narrative: Right side heart failure (which he has been hospitalized before); Has low indicators of heart disease (no cholesterol and no triglycerides); heart failure was associated with his COPD; 2 types of cancer; on of the being lung cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 02Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 02), administration date: Jan2021, for COVID-19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "2 types of cancer"; LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "on of the being lung cancer"; CARDIAC FAILURE (hospitalization), outcome "unknown", described as "Right side heart failure (which he has been hospitalized before)"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has low indicators of heart disease (no cholesterol and no triglycerides)"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "heart failure was associated with his COPD". The patient underwent the following laboratory tests and procedures: total lung capacity: 65 %, notes: COPD with a lung capacity of 65%.  Clinical Course: The patient had comorbidities. He was aware that the efficacy of the vaccine wanes after 6 months and wished to get information on if he would be able to get a second booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Bursitis, Pain assessment, Ultrasound scan
Clinical narrative: subacromial-subdeltoid bursitis; This is a literature report for the following literature source(s).  A 38 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization, reaction(s): "moderate arm pain around the injection site". The following information was reported: BURSITIS (medically significant), outcome "recovered", described as "subacromial-subdeltoid bursitis". The patient underwent the following laboratory tests and procedures: pain assessment: 10/10; ultrasound scan: left shoulder was performed in which subacromial, notes: subdeltoid bursitis was detected.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-20220029551 Same article/drug/patient; different event.;US-PFIZER INC-202200295513 Same article/drug/event and Different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 7-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event got COVID cannot be excluded based on temporal association and available information.,Linked Report(s) : US-PFIZER INC-202101723682 Same patient, different vaccine dose number and different event.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Constipation, Diarrhoea, Flatulence
Clinical narrative: Severe stomach trouble; Nausea; Constipation; Diarrhea; cramping; Bloating; gassy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 17:45 (Lot number: 33025BD) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Severe stomach trouble"; NAUSEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Nausea"; CONSTIPATION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Constipation"; DIARRHOEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Diarrhea"; MUSCLE SPASMS (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "cramping"; ABDOMINAL DISTENSION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "gassy". Therapeutic measures were not taken as a result of abdominal discomfort, nausea, constipation, diarrhoea, muscle spasms, abdominal distension, flatulence.  Additional information: The patient did not receive other Vaccine in four weeks. The patient had not covid prior vaccination. The patient has not covid tested post vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea
Clinical narrative: Severe stomach trouble; Nausea; Constipation; Diarrhea; cramping; Bloating; gassy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 17:45 (Lot number: 33025BD) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Severe stomach trouble"; NAUSEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Nausea"; CONSTIPATION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Constipation"; DIARRHOEA (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Diarrhea"; MUSCLE SPASMS (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "cramping"; ABDOMINAL DISTENSION (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "gassy". Therapeutic measures were not taken as a result of abdominal discomfort, nausea, constipation, diarrhoea, muscle spasms, abdominal distension, flatulence.  Additional information: The patient did not receive other Vaccine in four weeks. The patient had not covid prior vaccination. The patient has not covid tested post vaccination.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Biopsy, Cutaneous lupus erythematosus, Pathology test
Clinical narrative: Cutaneous lupus erythematosus; This is a literature report.  A male patient in his 60's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "Lung cancer" (unspecified if ongoing); "Erythema" (unspecified if ongoing); "Peripheral scaling on the abdomen, back, and bilateral upper extremities" (unspecified if ongoing); "Focal Hyperkeratosis" (unspecified if ongoing); "Necrotic keratinocytes" (unspecified if ongoing); "Lupus erythematosus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single Manufacturer: unknown), for COVID-19 immunization. The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (death, medically significant), outcome "fatal", described as "Cutaneous lupus erythematosus". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:540, notes: and the patient was positive for anti-SSA/Ro antibodies; biopsy: showed an interface lymphocytic infiltrate with, notes: vacuolar changes of the basal cells. The epidermis demonstrated focal hyperkeratosis and few necrotic keratinocytes were noted; pathology test: stated that the findings could be consistent, notes: with the clinical impression of a drug reaction and differential diagnosis as lupus erythematosus. Therapeutic measures were taken as a result of cutaneous lupus erythematosus. The patient date of death was unknown. The reported cause of death was lung neoplasm malignant. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded or assessed. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Lung Cancer
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Left ventricular end-diastolic pressure, Myocarditis, Troponin
Clinical narrative: Myopericarditis following COVID-19 Booster Dose; This is a literature report for the following literature source(s)  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "unknown", described as "Myopericarditis following COVID-19 Booster Dose". The patient was hospitalized for myocarditis (hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: st elevations; left ventricular end-diastolic pressure: 60 %; troponin: 10.4 ug/L.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information in the case, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient.;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Left ventricular end-diastolic pressure, Myocarditis, Troponin
Clinical narrative: Myopericarditis following COVID-19 Booster Dose; This is a literature report for the following literature source(s).  An adult 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "unknown", described as "Myopericarditis following COVID-19 Booster Dose". The event "myopericarditis following covid-19 booster dose" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: diffuse st changes; left ventricular end-diastolic pressure: 55 %; troponin: less than 0.01.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Left ventricular end-diastolic pressure, Myocarditis, Troponin
Clinical narrative: mild myocarditis; This is a literature report.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (J&J), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "unknown", described as "mild myocarditis". The event "mild myocarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: st abnormality; left ventricular end-diastolic pressure: 60-65 %; troponin: 0.04 ug/L.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Sex: M
Vaccine: COVID19
Symptoms: Cardiogenic shock, Chest pain, Electrocardiogram, Left ventricular end-diastolic pressure, Myocarditis
Clinical narrative: chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; This is a literature report for the following literature source(s): "Surveillance of Myopericarditis following COVID-19 Booster Dose Vaccination in a Large Integrated Health System", medRxiv, 2022; DOI:10.1101/2022.02.08.22270635.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), CHEST PAIN (hospitalization, life threatening), CARDIOGENIC SHOCK (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "chest pain, myocarditis, and cardiogenic shock after his booster dose". The patient was hospitalized for myocarditis, chest pain, cardiogenic shock (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: sinus tach; left ventricular end-diastolic pressure: 35-40 %; troponin: 17.8 ug/L.  The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; chest pain, myocarditis, and cardiogenic shock after his booster dose; This is a literature report for the following literature source(s): "Surveillance of Myopericarditis following COVID-19 Booster Dose Vaccination in a Large Integrated Health System", medRxiv, 2022; DOI:10.1101/2022.02.08.22270635.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), CHEST PAIN (hospitalization, life threatening), CARDIOGENIC SHOCK (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "chest pain, myocarditis, and cardiogenic shock after his booster dose". The patient was hospitalized for myocarditis, chest pain, cardiogenic shock (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: electrocardiogram: sinus tach; left ventricular end-diastolic pressure: 35-40 %; troponin: 17.8 ug/L.  The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node underarm; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2022 at 12:30 (Lot number: FK9896) at the age of 37 years as dose 2 (tris), single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FL3209; Anatomical site: Left arm), administration date: 21Jan2022, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Feb2022 at 22:00, outcome "unknown", described as "Swollen lymph node underarm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Mental status changes, Nausea, Syncope
Clinical narrative: ANAPHYLACTIC REACTION; Episode of syncope; Headache; Altered mental status; Nausea; Vomiting; This is a literature report for the following literature source(s): privacy  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "MDD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant, life threatening), outcome "unknown", described as "ANAPHYLACTIC REACTION"; SYNCOPE (medically significant), outcome "unknown", described as "Episode of syncope"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "Altered mental status"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting".  No Follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out 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: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: ANAPHYLACTIC REACTION; Episode of syncope; Headache; Altered mental status; Nausea; Vomiting; This is a literature report for the following literature source(s): privacy  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaphylaxis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "MDD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant, life threatening), outcome "unknown", described as "ANAPHYLACTIC REACTION"; SYNCOPE (medically significant), outcome "unknown", described as "Episode of syncope"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MENTAL STATUS CHANGES (non-serious), outcome "unknown", described as "Altered mental status"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting".  No Follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, HIV test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190023-00.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 06Dec2021 (Lot number: TH2027) at the age of 46 years as dose 3 (booster), single, intramuscular, administration date 11May2021 (Lot number: EW0183) as dose 2, single and intramuscular, administration date 13Apr2021 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ex tobacco user", start date: 1989, stop date: 2014, notes: smoked cigars and a pack of cigarettes a day; "smoked cigars", start date: 1989, stop date: 2014, notes: smoked cigars and a pack of cigarettes a day; "alcohol use", start date: 1994 (unspecified if ongoing), notes: alcohol use,rarely drinks beer or rhum or cocktail; "Unable To Work" (unspecified if ongoing), notes: Disabled As Patient Was Unable To Work Like It Used To; "Acid reflux" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sinus allergy" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease; BUPROPION taken for anxiety; LORATADINE taken for allergic sinusitis; FLONASE [FLUTICASONE PROPIONATE] taken for allergic sinusitis; FINASTERIDE taken for alopecia; HUMIRA taken for hidradenitis, start date: 05Aug2021 (ongoing). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: hiv test: (Jan2022) negative; sars-cov-2 test: (09Jan2022) positive.  No follow-up attempts are needed. No further information is expected.