chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Memory impairment
Clinical narrative: Moderate to severe fatigue; loss of appetite; memory was temporarily impacted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, MANUFACTURER UNKNOWN, These effects were more, pronounced than side effects the individual had as of the first or second vaccine dose.), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, MANUFACTURER UNKNOWN, These effects were more, pronounced than side effects the individual had as of the first or second vaccine dose.), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "Moderate to severe fatigue"; DECREASED APPETITE (non-serious), outcome "recovering", described as "loss of appetite"; MEMORY IMPAIRMENT (non-serious), outcome "recovering", described as "memory was temporarily impacted".  Additional information: I received the following adverse event report for the Comirnaty booster injection (3rd injection) today: Side effects was moderate to severe fatigue and loss of appetite lasting 3 or more days after the injection. Subject indicated that memory was temporarily impacted, which could have been due to fatigue noted above. The individual was recovering as of my receiving this report. These effects were more pronounced than side effects the individual had as of the first or second vaccine dose. Date adverse event report received: 26Jan2022 at ca. 7:30 PM.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LupusMi-AE2021.12.23.01. 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: SEIZURE (medically significant), outcome "unknown", described as "Seizures". Clinical course: it was mentioned that Pfizer vaccine gave patient and others seizures.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphocytic hypophysitis, Magnetic resonance imaging, Malaise
Clinical narrative: severe malaise; immune-related hypophysitis; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "mRCC" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "severe malaise"; LYMPHOCYTIC HYPOPHYSITIS (non-serious), outcome "unknown", described as "immune-related hypophysitis". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Patient receiving pembrolizumab/axitinib for mRCC since 12Feb2021and with no major side effects, received a Pfizer booster shot and within 24 hours experienced severe malaise and immune-related hypophysitis, diagnosed by MRI on 18Sep. Since then, she has experienced decreased response to pembrolizumab/axitinib, with plans to change therapy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Headache
Clinical narrative: Off label use; Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna; Chills; Headache; Muscle pain; Arm pain; Fatigue; Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FJ6369) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that prior to vaccination the patient was not diagnosed with COVID-19. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 038A21A), for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: 037B21A), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Covid test result=Positive"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. It was reported that patient has been tested for COVID-19 since the vaccination.  Clinical course: It was reported that seriousness criteria was not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Device date was provided as 26Jan2022.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Myalgia, Off label use, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Off label use; Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna; Chills; Headache; Muscle pain; Arm pain; Fatigue; Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FJ6369) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that prior to vaccination the patient was not diagnosed with COVID-19. Vaccination history included: Moderna (Dose Number: 1, Batch/Lot No: 038A21A), for COVID-19 immunization; Moderna (Dose Number: 2, Batch/Lot No: 037B21A), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose_number=3, brand=Pfizer, prev_dose_brand=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Covid test result=Positive"; CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive. It was reported that patient has been tested for COVID-19 since the vaccination.  Clinical course: It was reported that seriousness criteria was not resulted in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect. Device date was provided as 26Jan2022.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: experience anaphylactic reactions for both of her dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "experience anaphylactic reactions for both of her dose".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Dizziness, Dyspnoea, Type I hypersensitivity
Clinical narrative: Intermittent hypersensitivity reactions; Dyspnea; Lightheadedness; This is a literature report for the following literature source(s):   Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer-BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  Symptoms After First Dose: Dyspnea, lightheadedness. Time to Symptom Onset was 10 min. Treatment After First Dose was Albuterol. No ED (emergency department) Evaluation, no Skin Test Performed.  A 40 year-old female patient received bnt162b2 (Manufacturer Pfizer- BioNTech) (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Intermittent hypersensitivity reactions"; DYSPNOEA (medically significant), outcome "unknown", described as "Dyspnea"; DIZZINESS (medically significant), outcome "unknown", described as "Lightheadedness". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: unknown results. Symptoms After First Dose: Dyspnea, lightheadedness. Time to Symptom Onset was 10 min. Treatment After First Dose was Albuterol. No ED (emergency department) Evaluation, no Skin Test Performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on possible temporal association the causal role of BNT162b2 cannot be excluded and assessed as related for the reported events.  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) : PFIZER INC-202200156861 Same article/ drug/event and different patient:; PFIZER INC-202200156865 Same article/ drug/event and different patient; PFIZER INC-202200156864 Same article/ drug/event and different patient; PFIZER INC-202200156863 Same article/ drug/event and different patient; PFIZER INC-202200156862 Same article/ drug/event and different patient; PFIZER INC-202200156866 Same article/ drug/event and different patient
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Breakthrough case of COVID-19.; Breakthrough case of COVID-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "Breakthrough case of COVID-19.". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection
Clinical narrative: he has Covid starting around 28Dec2021 through 04Jan2022; he has Covid starting around 28Dec2021 through 04Jan2022; he might have a breakthrough infection way back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hepatitis b; Hiv. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he has Covid starting around 28Dec2021 through 04Jan2022"; INFECTION (non-serious), outcome "unknown", described as "he might have a breakthrough infection way back".  Clinical course: Patient would like to inquire on how to volunteer on getting the Omicron specific vaccine clinical trials. He mentioned that he already got the 3 doses of the Pfizer covid-19 vaccine. He would like to know whether or not he will be an acceptable candidate. He also mentioned that he might have a breakthrough infection way back and was advised that if he continues to get weird symptoms, He needs to get tested but he was never tested. He also mentioned that he has Covid starting around 28Dec2021, through 04Jan2022. Patient also mentioned he was a volunteer of many vaccine trials for Hepatitis B and C as well as HIV.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Investigation, SARS-CoV-2 test
Clinical narrative: no stamina at all; Brain fog lasted 3 months; daily headaches; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 15Aug2021 17:30 (Lot number: ew0179) at the age of 64 years as dose 3 (booster), single for COVID-19 immunization. The vaccination facility type was the pharmacy/drug store. Relevant medical history included: "Immune issues" (unspecified if ongoing). Concomitant medications included: fluticasone propionate (FLOVENT); montelukast sodium (SINGULAIR). Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Lot number: el3246, vaccine location: right arm), administration date/time: 14Jan2022 at 09:00 AM, when the patient was 63 years old, for COVID-19 immunization; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 2, single; Lot number: el9265, vaccine location: right arm), administration date/time: 05Feb2021 at 08:00 AM, when the patient was 64 years old, for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. The following information was reported: FATIGUE (disability) with onset 16Aug2021 10:30, outcome "not recovered," described as "no stamina at all"; FEELING ABNORMAL (disability) with onset 16Aug2021 10:30, outcome "recovered" (Nov2021), described as "Brain fog lasted 3 months"; HEADACHE (disability) with onset 16Aug2021 10:30, outcome "not recovered," described as "daily headaches." After 6 months, the patient had all types of tests by cardiologists and neurologist. The patient did not have headaches before and was a marathon runner. She no longer run. The adverse events (AE) resulted in disability or permanent damage. The events "no stamina at all," "brain fog lasted 3 months," and "daily headaches" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: tests: (unspecified date) unknown result, notes: all types of tests by cardiologists and neurologist; Binax (SARS-CoV-2 test): (25Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of fatigue, feeling abnormal, headache.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID 19 case.; Breakthrough COVID 19 case.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received bnt162b2 (BNT162B2) (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) all with onset 27Jan2022, outcome "unknown" and all described as "Breakthrough COVID 19 case." It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left wrist then fingers, then entire left arm tingling that moved to neck/jaw area, then entire right arm/tingled in face; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: ER8731) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history [other medical history: No]. No known allergies. There were no concomitant medications. On 08Apr2021, the patient experienced his left wrist then fingers, then entire left arm tingling that moved to neck/jaw area, then entire right arm/tingled in face (disability) with outcome of recovered. Clinical course details: After the first shot, the patient's left wrist then fingers, then entire left arm tingling, that moved to neck/jaw area, then entire right arm. Lasted for about 2 hours after the shot in full affect. Still tingled in face some around 24 hours later on and off. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. No prolonged hospitalization occurred.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Type I hypersensitivity, Urticaria
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose; Urticaria; This is a literature report.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose. A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Urticaria". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 15.85, notes: log 2 dilution. Therapeutic measures were taken as a result of type i hypersensitivity, urticaria.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : PFIZER INC-202200151789 Same article/ drug/event and different patient:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood immunoglobulin G, Skin test, Type I hypersensitivity
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose; Angioedema; This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", Open Forum Infectious Diseases., 2021; Vol:8 (12), DOI:10.1093/ofid/ofab507.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose. A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant) with onset 2021, outcome "unknown", described as "Pfizer-BioNTech COVID-19 Vaccine in patient with immediate hypersensitivity reaction to the first dose"; ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 16.85, notes: log2 dilution; skin test: none. Therapeutic measures were not taken as a result of type i hypersensitivity, angioedema.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug and different patient/event.
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood immunoglobulin G, Rash, Skin test
Clinical narrative: Angioedema; Nonurticarial rash; This is a literature report for the following literature source(s): "Graded Administration of Second Dose of Moderna and Pfizer-BioNTech COVID-19 mRNA Vaccines in Patients with Hypersensitivity to First Dose", Open Forum Infectious Diseases., 2021; Vol:8 (12), DOI:10.1093/ofid/ofab507.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Nonurticarial rash". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: (2021) 16.85, notes: Log2 dilution; skin test: (2021) positive, notes: Intradermal; (2021) positive, notes: Intradermal; (2021) positive, notes: Intradermal. Therapeutic measures were taken as a result of angioedema, rash. Additional information: Reaction to Second Dose Via Graded Administration (Step Number) was none. Treatment With Graded Administration (Step Number) was none. Treatment after first dose included Diphenhydramine. Vaccine was administered between Jan2021 and May2021.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Blood immunoglobulin G, Dizziness, Dyspnoea, Nausea
Clinical narrative: Angioedema; Dyspnea; Lightheadedness; Nausea; This is a literature report.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnea"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Lightheadedness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". The events "angioedema", "dyspnea", "lightheadedness" and "nausea" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: (2021) 17.85, notes: Log2 dilution; skin test: (2021) none positive skin test component. Therapeutic measures were taken as a result of angioedema, dyspnoea, dizziness, nausea. Additional information: Treatment after first dose included Epinephrine. Vaccine was administered between Jan2021 and May2021. Reaction to second dose via graded administration (Step Number) included dyspnea, pruritus. Treatment with graded administration (Step Number) included Albuterol, cetirizine.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Skin test
Clinical narrative: Angioedema; Dyspnea; Lightheadedness; Nausea; This is a literature report.  Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant) with onset 2021, outcome "unknown", described as "Angioedema"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnea"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Lightheadedness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". The events "angioedema", "dyspnea", "lightheadedness" and "nausea" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: (2021) 17.85, notes: Log2 dilution; skin test: (2021) none positive skin test component. Therapeutic measures were taken as a result of angioedema, dyspnoea, dizziness, nausea. Additional information: Treatment after first dose included Epinephrine. Vaccine was administered between Jan2021 and May2021. Reaction to second dose via graded administration (Step Number) included dyspnea, pruritus. Treatment with graded administration (Step Number) included Albuterol, cetirizine.; Sender's Comments: Based on the information currently available, a role of bnt162b2 vaccine in this patient cannot be completely excluded,Linked Report(s) : US-PFIZER INC-202200151789 Same article/drug, different patient
Sex: F
Vaccine: COVID19, UNK
Symptoms: Breakthrough pain, Drug ineffective, Drug specific antibody present, Impaired quality of life, Insomnia
Clinical narrative: Rheumatoid arthritis flare up; Lack of drug effect; Impaired quality of life; Difficulty sleeping; Drug specific antibody present; Breakthrough pain; 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-163-4238973-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number: unknown) to 2021 at (40mg/0.4ml) for rheumatoid arthritis. Relevant medical history included: "Allergic Rhinitis Unspecified" (unspecified if ongoing); "Gastro Esophageal Reflux Discharge without Esophagitis" (unspecified if ongoing); "Opoid use unspecified uncomplicated asthma" (unspecified if ongoing); "Unspecified disturbances of skin sensation" (unspecified if ongoing); "Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement" (unspecified if ongoing); "Intervertebral disc degeneration thoracic region" (unspecified if ongoing); "Sulfacetamide allergy" (unspecified if ongoing); "Bactrim Allergy" (unspecified if ongoing); "Ibuprofen Allergy" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; FLUTICASONE; ALBUTEROL SULFATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL; ACETAMINOPHEN;HYDROCODONE; IBUPROFEN. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INEFFECTIVE (non-serious), outcome "not recovered", described as "Lack of drug effect"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "not recovered", described as "Impaired quality of life"; INSOMNIA (non-serious), outcome "not recovered", described as "Difficulty sleeping"; DRUG SPECIFIC ANTIBODY PRESENT (non-serious), outcome "not recovered", described as "Drug specific antibody present"; BREAKTHROUGH PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Breakthrough pain". The patient underwent the following laboratory tests and procedures: laboratory test: unk. The action taken for adalimumab was dosage permanently withdrawn on 2021. Clinical information:  The reporter's causality for Pfizer biontech covid-19 vaccine (tozinameran) and HUMIRA 40mg/0.4ml (ADALIMUMAB), for the event(s) of affecting quality of life, unable to sleep, rheumatoid arthritis/ worsened/ flare up, Humira not working due to formation of antibodies unknown onset and breakthrough pain 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: As there is limited information in the case provided, the causal association between the reported events and the suspect vaccine BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Lack of drug effect; Impaired quality of life; Difficulty sleeping; Drug specific antibody present; Breakthrough pain; 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-163-4238973-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number: unknown) to 2021 at (40mg/0.4ml) for rheumatoid arthritis. Relevant medical history included: "Allergic Rhinitis Unspecified" (unspecified if ongoing); "Gastro Esophageal Reflux Discharge without Esophagitis" (unspecified if ongoing); "Opoid use unspecified uncomplicated asthma" (unspecified if ongoing); "Unspecified disturbances of skin sensation" (unspecified if ongoing); "Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement" (unspecified if ongoing); "Intervertebral disc degeneration thoracic region" (unspecified if ongoing); "Sulfacetamide allergy" (unspecified if ongoing); "Bactrim Allergy" (unspecified if ongoing); "Ibuprofen Allergy" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; FLUTICASONE; ALBUTEROL SULFATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL; ACETAMINOPHEN;HYDROCODONE; IBUPROFEN. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INEFFECTIVE (non-serious), outcome "not recovered", described as "Lack of drug effect"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "not recovered", described as "Impaired quality of life"; INSOMNIA (non-serious), outcome "not recovered", described as "Difficulty sleeping"; DRUG SPECIFIC ANTIBODY PRESENT (non-serious), outcome "not recovered", described as "Drug specific antibody present"; BREAKTHROUGH PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Breakthrough pain". The patient underwent the following laboratory tests and procedures: laboratory test: unk. The action taken for adalimumab was dosage permanently withdrawn on 2021. Clinical information:  The reporter's causality for Pfizer biontech covid-19 vaccine (tozinameran) and HUMIRA 40mg/0.4ml (ADALIMUMAB), for the event(s) of affecting quality of life, unable to sleep, rheumatoid arthritis/ worsened/ flare up, Humira not working due to formation of antibodies unknown onset and breakthrough pain 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: As there is limited information in the case provided, the causal association between the reported events and the suspect vaccine BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Diverticulitis, Rash
Clinical narrative: but not sure if it was that or from being bedridden the week prior with diverticulitis.; Had mild rash; received by error of my physician a double of the booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER COVID-19 VACCINE) (Lot number: unknown) as dose 3 (booster), single, (Lot number: unknown) as dose 2, single and (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: DIVERTICULITIS (medically significant), outcome "unknown", described as "but not sure if it was that or from being bedridden the week prior with diverticulitis."; RASH (non-serious), outcome "unknown", described as "Had mild rash"; ACCIDENTAL OVERDOSE (non-serious), outcome "unknown", described as "received by error of my physician a double of the booster". Clinical course: Patient received the first two dose of the vaccine for COVID in the spring and received by error of the physician a double of the booster. Had mild rash, but not sure if it was that or from being bedridden the week prior with diverticulitis. Wanted to state that two family members had tested positive and patient hadn't had any symptoms of the virus. So patient must say good job. The vaccines did work and patient encourage everyone patient came into contact with to get the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent) for a Pfizer sponsored program (005570). A 26-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021, single dose, for COVID-19 immunisation. Medical history included autoimmune disorder (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The following patient experienced urticaria/she broke-out in head-to-toe hives (hospitalization) onset Apr 2021, with outcome of recovered. Therapeutic measures taken as a result of urticaria  included Benadryl. Additional information: Her neurologist was also made aware but had no recommendations. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Female individual says "I had Covid on Christmas this year, but I still had a great time".; Female individual says "I had Covid on Christmas this year, but I still had a great time".; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Dec2021 13:40, outcome "unknown" and all described as "Female individual says "I had Covid on Christmas this year, but I still had a great time"  Clinical course: Reporter reported "Happens at around minute marker 13:40. Female individual says "I had Covid on Christmas this year, but I still had a great time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jan2022 (Batch/Lot number: unknown) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FULVESTRANT; IBRANCE taken for breast cancer, start date: 26Aug2021 (ongoing). Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient was administered ibrance 125 mg by mouth daily for 21 days on and 7 days off in conjunction with fulvestrant (faslodex). Patient reported ongoing constipation and unpleasant taste in mouth after taking therapy since starting therapy. Patient reported most recent computed tomography scan resulted liver regeneration. Patient also reported headache and chills since receiving her covid-19 booster shot on 18Jan2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram normal, Magnetic resonance imaging head, Partial seizures
Clinical narrative: Developed focal consciousness impairing seizures on 29Sep2021; This is a spontaneous report received from contactable reporter(s) (Physician).  A 68 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administered in arm left, administration date 20Feb2021 (Lot number: EN6203) at the age of 67 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, Date/Time (24hr): 28Jan2021 , Anatomical site of injection: Upper right arm, Route of administration: Intramuscular, Batch/Lot number: EN9581), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: PARTIAL SEIZURES (medically significant) with onset 29Sep2021, outcome "not recovered", described as "Developed focal consciousness impairing seizures on 29Sep2021". The patient underwent the following laboratory tests and procedures: electroencephalogram normal: normal; magnetic resonance imaging head: showed stable 1.3 cm right temporal cavernous, notes: malformation without edema or recent hemorrhage. Therapeutic measures were taken as a result of partial seizures.  The reporter considered "developed focal consciousness impairing seizures on 29sep2021" not related to bnt162b2.  Clinical course: Developed focal consciousness impairing seizures on 29Sep2021 (1st witnessed). EEG normal. Brain MRI showed stable 1.3 cm right temporal cavernous malformation without edema or recent hemorrhage. Following that was prescribed medication Levetiracetam to stop seizures. He initially was non compliant and had additional seizures. Subsequently started Levetiracetam and developed side effect of depression and irritability. Subsequently changed to Lamotrigine for seizure prophylaxis which to this date has been helpful in preventing seizures. Reporter did not think patient's seizures are related to his Pfizer covid vaccines that he received 28Jan2021, 20Feb2021 and 01Oct2021. Reporter did not consider Pfizer product had a causal effect to the adverse event.; Sender's Comments: The event focal consciousness impairing seizures  is assessed as likely due to the cavernous malformation and assessed as unrelated to BNT162B2 vaccine administration.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: my daughters and husband contacted covid-19 in spite having their vaccination; my daughters and husband contacted covid-19 in spite having their vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 5 years 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "my daughters and husband contacted covid-19 in spite having their vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive, notes: they had PCR test this morning but we don not have those results. The antigen test were positive."; (27Jan2022) unknown results, notes: they had PCR test this morning but we don not have those results. The antigen test were positive.". Therapeutic measures were taken as a result of covid-19.  Additional information: Tylenol was taken as treatment. NDC number, UPC number, expiry date were reported as unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: severe pain in the right foot; This severely affected their mobility; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 29Apr2021 10:00 (Lot number: EW0171) at the age of 36 years as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the pharmacy/drug store. The patient had no relevant medical history; the patient had no known allergies. There were no concomitant medications; the patient had not received any other medications within 2 weeks of vaccination. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Batch/Lot number: ER8731, location of injection: left arm), administration date: 08Apr2021, when the patient was 36 years old, for COVID-19 immunization, reaction: "left wrist then fingers, then entire left arm tingling, that moved to neck/jaw area, then entire right arm (lasted for about 2 hours after the shot in full affect)/tingled in face (still tingled in face some around 24 hours later on and off)." The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: PAIN IN EXTREMITY (disability) with onset 01Jun2021, outcome "not recovered," described as "severe pain in the right foot"; MOBILITY DECREASED (disability) with onset 01Jun2021, outcome "not recovered," described as "This severely affected their mobility." It was further reported that there was no immediate reaction. After about a month or 2, the patient developed severe pain in his right foot, especially when standing or walking on it; he still have this at the time of the report. That alone might not be interesting, but his wife developed the same thing about a month or 2 after her 2nd dose as well and still had that pain today. This severely affected their mobility and was very annoying to deal with. The patient had yet to move on his 3rd dose as he was worried it could make it worse than it already was or he would get pain in another area. The patient had not seen a doctor about this as he had not had the time to go and he was hoping it would just go away. The adverse event resulted in disability or permanent damage. Therapeutic measures were not taken as a result of pain in extremity, mobility decreased.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200157496 same reporter, product, and event; different patient