chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram, Ejection fraction, Electrocardiogram
Clinical narrative: acute chest pain; Myocarditis; Pericardial effusion; This is a literature report.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant), outcome "recovering", described as "Pericardial effusion"; CHEST PAIN (hospitalization), outcome "recovering", described as "acute chest pain". The patient was hospitalized for myocarditis, pericardial effusion (hospitalization duration: 3 day(s)). The events "myocarditis" and "pericardial effusion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: 18.00 mg/dl; echocardiogram: biventricular size: normal, notes: Biventricular function: Normal Additional findings: Hyperechoic septum; ejection fraction: 60 %; 58 %; electrocardiogram: diffuse st elevation; electrocardiogram qrs complex abnormal: normal; investigation: negative; laboratory test: normal; 5, 6, and 12; 71, notes: mL/m2; 69, notes: mL/m2; magnetic resonance imaging heart: interval between vaccination and mri (d): 5, notes: LVEF (left ventricular ejection fraction): 60% RVEF (right ventricular ejection fraction): 58%; LVEDV (left ventricular end-diastolic volume) /BSA: 71 mL/m2; RVEDV (right ventricular end-diastolic volume): 69 mL/m2; Early gadolinium enhancement: Yes; Late gadolinium enhancement: Yes; Distribution of enhancement: 5, 6, and 12; Myocardial edema: No; Pericardial effusion: Trace; yes; yes; respiratory viral panel: igg ebv antibodies; troponin i: 4.91 ng/ml. Therapeutic measures were taken as a result of myocarditis, pericardial effusion.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Myocarditis , Pericardial effusion, Chest pain 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.,Linked Report(s) : US-PFIZER INC-202200355287 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram QRS complex abnormal, Investigation, Laboratory test, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: acute chest pain; Myocarditis; Pericardial effusion; This is a literature report.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant), outcome "recovering", described as "Pericardial effusion"; CHEST PAIN (hospitalization), outcome "recovering", described as "acute chest pain". The patient was hospitalized for myocarditis, pericardial effusion (hospitalization duration: 3 day(s)). The events "myocarditis" and "pericardial effusion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: 18.00 mg/dl; echocardiogram: biventricular size: normal, notes: Biventricular function: Normal Additional findings: Hyperechoic septum; ejection fraction: 60 %; 58 %; electrocardiogram: diffuse st elevation; electrocardiogram qrs complex abnormal: normal; investigation: negative; laboratory test: normal; 5, 6, and 12; 71, notes: mL/m2; 69, notes: mL/m2; magnetic resonance imaging heart: interval between vaccination and mri (d): 5, notes: LVEF (left ventricular ejection fraction): 60% RVEF (right ventricular ejection fraction): 58%; LVEDV (left ventricular end-diastolic volume) /BSA: 71 mL/m2; RVEDV (right ventricular end-diastolic volume): 69 mL/m2; Early gadolinium enhancement: Yes; Late gadolinium enhancement: Yes; Distribution of enhancement: 5, 6, and 12; Myocardial edema: No; Pericardial effusion: Trace; yes; yes; respiratory viral panel: igg ebv antibodies; troponin i: 4.91 ng/ml. Therapeutic measures were taken as a result of myocarditis, pericardial effusion.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Myocarditis , Pericardial effusion, Chest pain 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.,Linked Report(s) : US-PFIZER INC-202200355287 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Respiratory viral panel, Troponin I
Clinical narrative: acute chest pain; Myocarditis; Pericardial effusion; This is a literature report.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis"; PERICARDIAL EFFUSION (hospitalization, medically significant), outcome "recovering", described as "Pericardial effusion"; CHEST PAIN (hospitalization), outcome "recovering", described as "acute chest pain". The patient was hospitalized for myocarditis, pericardial effusion (hospitalization duration: 3 day(s)). The events "myocarditis" and "pericardial effusion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: 18.00 mg/dl; echocardiogram: biventricular size: normal, notes: Biventricular function: Normal Additional findings: Hyperechoic septum; ejection fraction: 60 %; 58 %; electrocardiogram: diffuse st elevation; electrocardiogram qrs complex abnormal: normal; investigation: negative; laboratory test: normal; 5, 6, and 12; 71, notes: mL/m2; 69, notes: mL/m2; magnetic resonance imaging heart: interval between vaccination and mri (d): 5, notes: LVEF (left ventricular ejection fraction): 60% RVEF (right ventricular ejection fraction): 58%; LVEDV (left ventricular end-diastolic volume) /BSA: 71 mL/m2; RVEDV (right ventricular end-diastolic volume): 69 mL/m2; Early gadolinium enhancement: Yes; Late gadolinium enhancement: Yes; Distribution of enhancement: 5, 6, and 12; Myocardial edema: No; Pericardial effusion: Trace; yes; yes; respiratory viral panel: igg ebv antibodies; troponin i: 4.91 ng/ml. Therapeutic measures were taken as a result of myocarditis, pericardial effusion.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events Myocarditis , Pericardial effusion, Chest pain 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.,Linked Report(s) : US-PFIZER INC-202200355287 Same article/ drug/event and different patient
Age: 61.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4289030-00 (Agency).  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis, psoriasis, colitis ulcerative; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 04Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "Mycoplasma infection". The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 25Feb2021, outcome "recovered" (01Mar2021), described as "Rheumatoid arthritis flare up". The action taken for upadacitinib and adalimumab was unknown. Clinical course:The reporter causality for the event of rheumatoid arthritis flare up was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: based on a positive temporal relationship, causal relationship between the reported event rheumatoid arthritis and the suspect 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 20-year-old female patient received bnt162b2 (BNT162B2), administered in the left arm, administration date 14Aug2021 at 09:15, (Lot number: EW0173) at the age of 20 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: TRI FEMYNOR and unspecified birth control medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 05Sep2021, outcome "not recovered", described as "I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine". The event "I have been getting my period for long periods of time, heavier flows, all of which I have NEVER experienced prior to vaccine" 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 heavy menstrual bleeding.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 09Sep2021 at 18:30, (Lot number: EW0173) at the age of 20 years as dose 2, single for COVID-19 immunisation.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Lymphoma, Pain in extremity, Splenomegaly
Clinical narrative: enlarged and painful lymphoma; took both shots in Oct and has been week since; enlarged spleen; pain in legs and head; pain in legs and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 2, single and administration date Oct2021 (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: ASTHENIA (non-serious), outcome "unknown", described as "took both shots in Oct and has been week since"; the patient had been to doctor 4 times with SPLENOMEGALY (non-serious), outcome "unknown", described as "enlarged spleen", LYMPHOMA (medically significant), outcome "unknown", described as "enlarged and painful lymphoma", HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "pain in legs and head". The events "enlarged and painful lymphoma", "took both shots in oct and has been week since", "enlarged spleen", "pain in legs and head" and "pain in legs and head" were evaluated at the physician office visit. The doctor had no idea how to help him.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Had sudden onset of menstrual bleeding. Even when I wasn't due for more than a week; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 24-year-old female patient (not pregnant) received COVID-19 VACCINE - MANUFACTURER UNKNOWN, administered in left arm, administration date 02Mar2022 at 18:00 (Lot number: unknown) at the age of 24 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included unspecified birth control medication. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Mar2022 at 23:00, outcome "not recovered", described as "Had sudden onset of menstrual bleeding. Even when I wasn't due for more than a week". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: It was reported that the patient was fairly regular and never had breakthrough bleedings, so it wasn't something else that she had been doing like she normally does that's caused it. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Menstruation was much heavier than normal; Also a few days later I noticed an achy pain in my right arm that has persisted longer than a month now.; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 31Jan2022 at 16:00 (Lot number: unknown) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing) and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included unspecified multivitamin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FJ1611; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 03Jan2022, when the patient was 35 years old, for COVID-19 immunisation.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Menstruation was much heavier than normal"; PAIN IN EXTREMITY (non-serious) with onset 02Feb2022, outcome "not recovered", described as "Also a few days later I noticed an achy pain in my right arm that has persisted longer than a month now." Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the result was negative.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haematoma
Clinical narrative: I got my fourth Pfizer shot a couple of weeks ago, and I got a big hematoma at the site; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She said she's an immunocompromised person . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE HAEMATOMA (non-serious), outcome "unknown", described as "I got my fourth Pfizer shot a couple of weeks ago, and I got a big hematoma at the site".  Additional information: Patient explained that, explained that she had hematoma after getting her 4th dose of Pfizer covid vaccine. She said she was an immunocompromised person and she worries that maybe the shot did not go into the muscle and that she did not get the whole benefit of the vaccine. she wants to thank Pfizer for making a life-saving vaccine. She was truly grateful for our product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fibromyalgia worsened; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296449-00 (Agency).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Dec2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster) single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number: unknown; route: Intramuscular), administration date: 20Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, Single; Lot number: unknown; route: Intramuscular), administration date: 11May2021, for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "Rheumatoid arthritis flare up"; FIBROMYALGIA (non-serious) with onset Dec2021, outcome "unknown", described as "Fibromyalgia worsened".  Clinical course: It was stated that shortly after taking booster dose, had rheumatoid arthritis and fibromyalgia flare up that seemed to be worsened. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was related to Covid Vaccine. The reporter's causality for the events of rheumatoid arthritis flare up and fibromyalgia flare up with Rinvoq was no reasonable possibility. The reporter's causality for the events of rheumatoid arthritis flare up and fibromyalgia flare up with BNT162B2 vaccine was possible.  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 known drug temporal relationship and Limited information in the case report a casual association between reported events  with the suspect product BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: Stroke like symptoms; aphasia; This is a spontaneous report received from contactable nurse. The reporter is the patient.  A 59 year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FF2590), on 12Oct2021, when the patient was 59 years, as single dose for covid-19 immunisation. Relevant medical history included diabetes and high blood pressure (HBP), and  COVID prior to vaccination from unspecified dates. The patient took unspecified concomitant medications. Vaccination history included first dose of BNT162B2  (Lot number: 301308A), on  19Sep2021, when the patient was 59 years old, for covid-19 immunization. On 13Oct2021, the patient experienced stroke like symptoms and aphasia, which were serious as they were  life-threatening, and involved hospitalization. The patient was noted as desperately in need of insight.  The events  were evaluated at the physician office visit and emergency room visit. The patient underwent laboratory tests and procedures, which included unknown results from a COVID test, post vaccination.  Clinical details were as follows: Stroke like symptoms-aphasia-then total incapacity occurred. The patient was currently hospitalized, and noted as "desperately in need of insight ". The events involved hospitalization, and were life-threatening illness. There was no immediate risk of death from the event, and the patient was noted as hospitalized for 31 days. The patient had not recovered and treatment involved unspecified multiple interventions. The clinical outcome of stroke like symptoms and aphasia was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 12Jan2022 and second dose 1Feb2022/She inadvertently received a third dose today; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2022 (Batch/Lot number: unknown) as dose 3 (booster) (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 12Jan2022, for COVID-19 Immunization; Bnt162b2 (Dose:2), administration date: 01Feb2022, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Mar2022, outcome "unknown", described as "first dose on 12Jan2022 and second dose 1Feb2022/She inadvertently received a third dose today".  Additional information: Caller was inquiring about the product Pfizer COVID-19 vaccine orange cap 0.2 ml. Caller was calling on behalf of mother of a 10 years old female child. She received her first dose on 12Jan2022 and second dose 1Feb2022. She inadvertently received a third dose at 3:20 withheld time today. A written record of the second dose administered to the child was indicated on the vaccination card. Mother was unaware of the second dose and came in with the child to give her a second dose and not third. Caller has been diagnosed with learning disabilities. Caller was looking for guidance. A third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with orange caps and labels with orange borders (0.2 mL) at least 28 days following the second dose is authorized for administration to individuals 5 through 11 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Type 2 diabetes mellitus
Clinical narrative: Diagnosis of diabetes type 2 (6 months ago) 2021; Uncontrolled blood sugar ongoing "high" in the morning; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 46 year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 29Jul2020 (ongoing) (Batch/Lot number: unknown) at 11 mg 1x/day for rheumatoid arthritis; bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date May2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GLIPIZIDE. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant) with onset 2021, outcome "unknown", described as "Diagnosis of diabetes type 2 (6 months ago) 2021"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Uncontrolled blood sugar ongoing "high" in the morning". The patient underwent the following laboratory tests and procedures: blood glucose: (2021) high, notes: uncontrolled blood sugar ongoing "high" in the morning. The action taken for tofacitinib citrate was dosage not changed. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional Information: The patient initially, started the therapy on 29Jul2020; a break in therapy several times (product use error) due to covid 19 vaccinations, md held the therapy, several times due to covid 19 vaccines (Apr2021) 1st dose, May2021 2nd dose, Nov2021 3rd dose). She experienced rheumatoid arthritis "flareups" patient was unsure if this was also related to the covid 19 vaccination; however, improved after resuming the therapy. unknown md aware. recent diagnosis of diabetes type 2 (6 months ago) 2021, uncontrolled blood sugar ongoing "high" in the morning. md appointment to see endocrinologist scheduled. no further information, details, or dates, reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current information available, the event Type 2 diabetes mellitus mostly represented intercurrent condition in this patient unrelated to Xeljanz XR.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Knee arthroplasty, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Flu like symptoms; Total knee replacement; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296942-00 (Agency).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2022 at unk (citrate free) and second regimen subcutaneous since 28Feb2022 (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 26Feb2022, outcome "not recovered", described as "Total knee replacement"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "Flu like symptoms". The action taken for adalimumab was dosage not changed.  Clinical course: The patient had flu like symptoms from the first Covid vaccine but not for the other two. She stopped medication for two weeks prior to surgery. On 26Feb2022, she had gone through knee replacement surgery. She stated that it was in the middle of an arthritis flare and possibly it was the result of stopping therapy. Her hands and feet were swollen and painful. She was getting back on therapy just now as of 28Feb2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient also received second and third (booster) doses of Pfizer Biontech Covid-19 Vaccine with intramuscular route of administration. HUMIRA (Solution for injection in pre-filled pen)(Adalimumab) administered subcutaneously for moderate to severe rheumatoid Arthritis. The reporter's causality for the event(s) of KNEE REPLACEMENT SURGERY and FLU LIKE SYMPTOMS with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare with Humira (Adalimumab) was a reasonable possibility. The causality as per reporter for Pfizer Biontech Covid-19 Vaccine (Tozinameran) was provided as possible for event flu like symptoms and causality for the events of total knee replacement and rheumatoid arthritis flare up were not reported.  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 and a possible contributory role of suspect product BNT162B2 to the development of events influenza like illness cannot be totally excluded. Events total knee replacement and rheumatoid arthritis flare up are considered as intercurrent and assessed as not related to suspect product BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.; Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 03Mar2022 (Lot number: FE3594, Expiration Date: Nov2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose-1, Lot: FE3594), administration date: 10Feb2022, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (medically significant), EXPIRED PRODUCT ADMINISTERED (medically significant) all with onset 03Mar2022 and all described as "Caller states that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose.".  Clinical information: Reporter stated that 6 patients received the Pfizer-BioNTech COVID-19 Vaccine purple cap after its expiration date (28Feb2022), 2 as a first dose, 2 as a second dose and 2 as a booster dose. Reporter stated that vaccines were pulled back, but the pharmacist wasn't there and they forgot to mention it to him. 7 people, later clarified to 6, got those vaccines yesterday Reporter queried the level and they said she had 90 days, but the vaccines expired on Nov21, so the end of Feb2022 was the expiration Reporter states the seriousness is Medically Significant because the vaccines are not effective as they should be.; Sender's Comments: Based on information provided and temporal association, causal relationship between the reported events and the suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (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 (Dose: 01), for COVID-19 immunization. The following information was reported: ARTHRITIS REACTIVE (non-serious), outcome "recovering", described as "Reactive Arthritis". Therapeutic measures were taken as a result of arthritis reactive. Additional Information: Caller reported that, after getting her second dose on 11Aug2021, she developed Reactive Arthritis; currently she feels 99% better because of medication, but in her work they are asking her to take the booster shoot. Caller asks if there is an exemption to take the booster dose for her case. Caller expressed unconformity since there are not enough recommendations regarding exemptions of getting the vaccine for people having specific reactions. Caller also mentioned her opinion that doctors didn't care about administering the vaccine to people with previous reactions. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: joint pain and I'm talking about hand pain foot pain; joint pain and I'm talking about hand pain foot pain; joint pain and I'm talking about hand pain foot pain; 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 male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "joint pain and I'm talking about hand pain foot pain".  Additional information: I received the Pfizer vaccine sometime in March. Since then I haven't felt myself physically. (withheld) just tired and now I have some latent joint pain that I can't explain I'd like to know a little more about your vaccine can you let me know what's in the ingredients (see subsequent REQ for handling of ingredients inquiry) and is joint pain and I'm talking about hand pain foot pain etc as part of the list of side effects  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19; Since the vaccination, has the patient been tested for COVID-19; 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 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Nov2021 15:00 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single, administration date 30Mar2021 15:00 (Lot number: ER8733) as dose 2, single and administration date 09Mar2021 15:00 (Lot number: EN6706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression. Concomitant medication(s) included: BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive.  Clinical course: Patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19; Since the vaccination, has the patient been tested for COVID-19; 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 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Nov2021 15:00 (Lot number: FH8027) at the age of 46 years as dose 3 (booster), single, administration date 30Mar2021 15:00 (Lot number: ER8733) as dose 2, single and administration date 09Mar2021 15:00 (Lot number: EN6706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing), notes: other medical history: Depression. Concomitant medication(s) included: BUPROPION. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jan2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Jan2022) positive.  Clinical course: Patient had no allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diffuse alveolar damage
Clinical narrative: Diffuse Alveolar Hemorrhage; This is a literature report.   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIFFUSE ALVEOLAR DAMAGE (medically significant), outcome "unknown", described as "Diffuse Alveolar Hemorrhage".  ; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and Diffuse alveolar damage 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.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4294209-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single, intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk(citrate free) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Oct2021, outcome "unknown", COVID-19 (medically significant) with onset 27Oct2021, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Oct2021) positive, notes: experienced COVID-19. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of covid-19.  Clinical course:The patient had been sick since Dec2021, primary care physician referred the patient to the specialist physician to check her knees which were pretty worn out (bone on bone) and physician proposed knee replacement. She had pain and had gout for three months. Causality for Humira (Adalimumab):The reporter's causality for the event(s) of knees bone on bone worn out, sick and pain with Humira (Adalimumab) was a reasonable possibility and gout was not provided.The reporter's causality for the event(s) of knees bone on bone worn out, sick, Gout and pain with Pfizer BioNTech covid-19 vaccine was not reported. Causality for COVID-19:As per reporter (Drug/Vaccine): Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Hearing loss; This is a literature report for the following literature source(s): (Privacy).  A 53 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "autoimmune inner ear disease" (ongoing), notes: 7+ years. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on the available information in the case, the causal association between the event Hearing loss 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.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Tinnitus, Vertigo
Clinical narrative: Hearing loss; vertigo; Dizziness; Tinnitus; This is a literature report for the following literature source(s):(Privacy).  A 51 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (ongoing), notes: 5 years. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus". The events "hearing loss", "vertigo", "dizziness" and "tinnitus" were evaluated at the physician office visit.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear disorder, Tinnitus
Clinical narrative: Hearing loss; Tinnitus; Aural fullness; This is a literature report.  A 69 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Meniere's" (unspecified if ongoing), notes: 2 years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; TINNITUS (non-serious), outcome "unknown", described as "Tinnitus"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss", "tinnitus" and "aural fullness" were evaluated at the physician office visit.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness
Clinical narrative: Hearing loss; Dizziness; This is a literature report.  A 67 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune inner ear disease" (unspecified if ongoing), notes: 3+ years - stable; "Meniere's" (unspecified if ongoing), notes: 3+ years - stable. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness". The events "hearing loss" and "dizziness" were evaluated at the physician office visit.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported events 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