chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recurrent sinus infections" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details: Product for COVID 19 Treatment, brand was Paxlovid, treatment start date was13Jul2022 and treatment stop date was 22Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Electrocardiogram, Inappropriate schedule of product administration
Clinical narrative: Stroke; prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 at 10:00 as dose 2, single (Lot number: LR8727) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 05Dec2021 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; ALPRAZOLAM. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Administration time: 10:00, lot number: 338358D, Administration location: Left arm), administration date: 10Apr2021, when the patient was 61-year-old, for Covid-19 immunization; Flu (DOSE 1), for immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Dec2021 at 10:00, outcome "unknown", described as "prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021"; CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 20Jan2022, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (28Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient age group was reported as (18-64 Years). Patient received BNT162b2 on 10Apr2022 at 16:00 as dose 3, single (lot number: unknown) in left arm for covid-19 immunisation. Vaccination facility type reported as other pharmacy. Patient had not received any other vaccine in four weeks. Patient did not have covid prior vaccination and did not have any known allergies. Covid tested post vaccination. AE treatment was MRI, CT, ECHO, ECG therapy.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: Stroke; prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 at 10:00 as dose 2, single (Lot number: LR8727) at the age of 62 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 05Dec2021 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; ALPRAZOLAM. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Administration time: 10:00, lot number: 338358D, Administration location: Left arm), administration date: 10Apr2021, when the patient was 61-year-old, for Covid-19 immunization; Flu (DOSE 1), for immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Dec2021 at 10:00, outcome "unknown", described as "prev dose 1 administration date: 10Apr2021/ dose 2 administration date: 05Dec2021"; CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 20Jan2022, outcome "recovering", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results; Echocardiogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test: (28Jan2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: Patient age group was reported as (18-64 Years). Patient received BNT162b2 on 10Apr2022 at 16:00 as dose 3, single (lot number: unknown) in left arm for covid-19 immunisation. Vaccination facility type reported as other pharmacy. Patient had not received any other vaccine in four weeks. Patient did not have covid prior vaccination and did not have any known allergies. Covid tested post vaccination. AE treatment was MRI, CT, ECHO, ECG therapy.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2022 as dose number unknown, single (Lot number: En6200) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 07Jun2022 at 15:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "juvenile asthma" (unspecified if ongoing), notes: juvenile asthma; "Known allergies: Iodine contrast" (unspecified if ongoing), notes: Known allergies: Iodine contrast. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LARISSIA, start date: 03Feb2018. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor", notes: known allergies: Ceclor.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0150), in left arm and on 23Apr2021 as dose 2, single (Lot number: EW0170) at the age of 27 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Nov2021 as dose 3 (booster), single (Lot number: 064H21A), in left arm for covid-19 immunisation. The patient received vaccine. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "acne" (unspecified if ongoing); "arthritis" (unspecified if ongoing). No known allergies. Other medications in two weeks. Concomitant medication(s) included: BUSPIRONE; CLASCOTERONE; PROPANOLOL [PROPRANOLOL]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: Product COVID 19 treatment, Brand Paxlovid, treatment start date 28Jul2022 and lot number GD8763 for treatment of COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022; Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2022 as dose 4 (booster), single (Lot number: Fj5683) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage 1 Triple Negative Breast Cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer/BioNTech start date: 27Feb2022 / Paxlovid Treatment of COVID-19 start date: 10Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: There were no other medication in 2weeks. The patient had a cold and sniffles yesterday and woke up this morning to test and after a negative tea it came back positive. The patient had no known allergies. Paxlovid (lot number: 2815223) taken for Treatment of COVID-19. Treatment start date was reported as 10Jul2022. Treatment stop date was reported as 15Jul2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma; "former smoker" (unspecified if ongoing), notes: former smoker. There were no concomitant medications. There was no known allergies. There was no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Positive, notes: Relapse of positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment includes anti viral paxlovid which started from 13Jul2022 to 17Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 15:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto thyroid condition" (unspecified if ongoing). Concomitant medication(s) included: THYROID, start date: 17Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product: COVID 19 Treatment, Paxlovid, start date: 27Jul2022, lot number: NDC 00069-1085-30. Other medication in 2 weeks product: Thyroid with start date: 17Jan2021. Adverse event: Having a rebound after taking PAXLOVID. known allergies: No. Other medical history: Hashimoto thyroid condition  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Jul2022, outcome "recovering"; COVID-19 (medically significant) with onset 20Jul2022, outcome "recovering", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in two weeks. Patient did not received any treatment ae and did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neck pain, SARS-CoV-2 test, Spinal osteoarthritis
Clinical narrative: Pain in neck beginning approximately one week after vaccine; hypertrophic change in C1-C2 joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25May2021 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NECK PAIN (non-serious) with onset 02Jun2021, outcome "not recovered", described as "Pain in neck beginning approximately one week after vaccine"; SPINAL OSTEOARTHRITIS (non-serious) with onset 02Jun2021, outcome "not recovered", described as "hypertrophic change in C1-C2 joint". The events "pain in neck beginning approximately one week after vaccine" and "hypertrophic change in c1-c2 joint" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, spinal osteoarthritis.   Additional information: Pain in neck beginning approximately one week after vaccine. MRI results show hypertrophic change in C1-C2 joint. No injury or other reason for this change. Second dose given on 28Aug2021 on Left arm, Lot number: EWU179. Treatment received as Physical therapy, chiropractic treatment, MRI.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201006603 Same product, patient, different AEs, different dose;
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) in 2 weeks included: BUPROPION, start date: 01Sep2020, stop date: 28Jul2022. The patient was not pregnant at time of vaccination. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. It was reported that, the patient had prolonged terrible taste in mouth, similar to rotten grapefruit. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 27Jul2022 and stopped on 28Jul2022, Lot number: GA7394, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Crohn's disease, Depression, Diarrhoea
Clinical narrative: Depressed state; Crohn's disease; Anxiety; Sickness; Fatigue; Coughing; Diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435876-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Coughing"; DIARRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Diarrhea"; FATIGUE (non-serious) with onset Mar2022, outcome "recovered" (2022); ILLNESS (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Sickness"; ANXIETY (non-serious) with onset Jul2022, outcome "unknown"; CROHN'S DISEASE (medically significant) with onset Jul2022, outcome "recovered"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed state". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "crohn's disease", "sickness", "fatigue", "depressed state", "coughing", "diarrhea" and "anxiety" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information available, the causal relationship between the reported events and 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: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: Depressed state; Crohn's disease; Anxiety; Sickness; Fatigue; Coughing; Diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435876-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Coughing"; DIARRHOEA (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Diarrhea"; FATIGUE (non-serious) with onset Mar2022, outcome "recovered" (2022); ILLNESS (non-serious) with onset Mar2022, outcome "recovered" (2022), described as "Sickness"; ANXIETY (non-serious) with onset Jul2022, outcome "unknown"; CROHN'S DISEASE (medically significant) with onset Jul2022, outcome "recovered"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed state". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "crohn's disease", "sickness", "fatigue", "depressed state", "coughing", "diarrhea" and "anxiety" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information available, the causal relationship between the reported events and 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Afib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid on 21Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: 10 years old COVID 19 gray cap .3 ml FM7553; Headache; Sore arm; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 15Jun2022 as dose 3 (booster), 0.3 ml single (Lot number: FM7553) at the age of 10 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Anatomical site of injection; Left arm, Route of administration: Intramuscular, Batch/Lot number: FK5127), administration date: 14Nov2021, for COVID-19 Immunization; BNT162b2 (Dose: 2, Anatomical site of injection; Right arm, Batch/Lot number: FL8095), administration date: 02Jan2022, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered"; fluzone (Manufacturer: Sanofi, Batch/Lot number: 4T73378K, Route: Intramuscular, Anatomical site of injection: Right arm, No. of previous doses: 10), administration date: 27Oct2021, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 15Jun2022, outcome "unknown", described as "10 years old COVID 19 gray cap .3 ml FM7553"; HEADACHE (non-serious) with onset 2022, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovering", described as "Sore arm".  Additional information: It was reported that the patient's weight was 99.2 pounds. No underlying conditions. Event did not take place after use of the product. Patient did not provide information regarding the reported adverse event with the use of the product. Patient received 12 and older Pfizer COVID vaccine. After vaccination, soon had a headache and sore arm which were not major. Overall he was fine. Specific relevant test: For thromboembolic events with thrombocytopenia was None.  Follow-up (27Jul2022): This is a spontaneous follow-up report from a contactable other HCP. This other HCP reported in response to HCP letter [sent to other HCP] via follow-up letter which included that: Updated information included: Reporter details was updated and New reporters, Historical vaccine (vaccine administration date, anatomical site of injection, route of administration, batch/Lot number), Vaccination details RMH and New events (headache and sore arm) was added.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Middle ear effusion
Clinical narrative: Hearing loss; Fluid in middle ear; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4471789-00.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for  rheumatoid arthritis. The patient's relevant medical history included: "MODERATE TO SEVERE RHEUMATOID ARTHRITIS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "recovering", described as "Hearing loss"; MIDDLE EAR EFFUSION (non-serious), outcome "recovering", described as "Fluid in middle ear". The action taken for adalimumab was unknown.  Clinical course: Solicited report from a consumer of an elderly female with events of  HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR and non-serious HEARING LOSS DUE TO  BUILD UP OF FLUID IN EAR with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset and  HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility.  RA's opinion is that there is no reasonable possibility that the event of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset is related to HUMIRA(ADALIMUMAB). RA's opinion is that the event of HEARING LOSS DUE TO BUILD UP OF FLUID IN EAR unknown onset is not assessable.  The reporter considered "hearing loss" and "fluid in middle ear" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the 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.
Sex: U
Vaccine: COVID19
Symptoms: Eye movement disorder, Off label use, Product use issue, Seizure
Clinical narrative: 6-month-old patient received BNT162b2 (BNT162B2); 6-month-old patient received BNT162b2 (BNT162B2); A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization; A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: Unknown), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant), EYE MOVEMENT DISORDER (hospitalization), all with latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "A 6-month-old developed eye-rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization"; OFF LABEL USE (hospitalization, medically significant), PRODUCT USE ISSUE (hospitalization, medically significant), outcome "unknown" and all described as "6-month-old patient received BNT162b2 (BNT162B2)".  Clinical course: It was reported that a 6-month-old developed eye rolling seizures two days after the second dose of the Pfizer vaccine, leading to hospitalization. All symptoms resolved "17 days after onset," and the participant was withdrawn from the study by parental request."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID 19; contracted COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Although patient symptoms were mild and patient took Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: I had the second shot of Covid the Pfizershot. And I was paralyzed and was in the hospital; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "I had the second shot of Covid the Pfizershot. And I was paralyzed and was in the hospital". Therapeutic measures were taken as a result of paralysis. Clinical course: Caller called in to find out if Pfizer could provide them with financial assistance for a prescription the caller received from their HCP for a hospital bed. During the call caller stated. I had the second shot of Covid the Pfizer shot. And I was paralyzed and was in the hospital and still going to therapy and I got a prescription from the doctor to still get a bed, a hospital bed. Caller later stated on the call. The blood has to go into my legs better, and my head has to get more breathing and a little bit of the head has to be up in the bed and then the feet have to be up. Note: The patients date of birth was not provided during the call. Note: The reporters address and telephone number were not provided during the call. Note: During the call caller stated their last name but it was inaudible, unable to capture the callers last name for the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid-19 like symptoms; covid-19 like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4435876-00 (Agency).  A 24-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. 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), outcome "unknown" and all described as "covid-19 like symptoms". The action taken for adalimumab was unknown. The reporter considered "covid-19 like symptoms" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Suspected covid-19 and drug ineffective.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted Covid 19; Contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "Contracted Covid 19". Clinical course: Patient sister called and told me she contracted COVID. She was fully vaccinated with Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4380091-00.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2020 as dose 1, single (Batch/Lot number: unknown), on 02Apr2020 as dose 2, single (Batch/Lot number: unknown) and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abnormal faeces, COVID-19, Drug ineffective, Feeling cold, Insomnia
Clinical narrative: Feeling cold / Freezing/Had to use Three blankets; Productive cough / Coughing up a little bit like had sinus drainage; Sleep decreased / Averages about four hours of sleep; Pain in arm / Arm sore with Humira; Stool odor abnormal / Odor in Stool/Poop Smells Bad; COVID-19; COVID-19; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4289655-00 (Agency).  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk (citrate free), subcutaneous for colitis ulcerative. 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 23Dec2021, outcome "recovered" and all described as "COVID-19"; ABNORMAL FAECES (non-serious) with onset May2022, outcome "unknown", described as "Stool odor abnormal / Odor in Stool/Poop Smells Bad"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold / Freezing/Had to use Three blankets"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Productive cough / Coughing up a little bit like had sinus drainage"; INSOMNIA (non-serious), outcome "unknown", described as "Sleep decreased / Averages about four hours of sleep"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm / Arm sore with Humira". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Positive. The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19", "feeling cold / freezing/had to use three blankets", "productive cough / coughing up a little bit like had sinus drainage", "sleep decreased / averages about four hours of sleep" and "stool odor abnormal / odor in stool/poop smells bad" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pain in arm / arm sore with humira" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Productive cough, SARS-CoV-2 test
Clinical narrative: Feeling cold / Freezing/Had to use Three blankets; Productive cough / Coughing up a little bit like had sinus drainage; Sleep decreased / Averages about four hours of sleep; Pain in arm / Arm sore with Humira; Stool odor abnormal / Odor in Stool/Poop Smells Bad; COVID-19; COVID-19; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4289655-00 (Agency).  A 56-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk (citrate free), subcutaneous for colitis ulcerative. 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 23Dec2021, outcome "recovered" and all described as "COVID-19"; ABNORMAL FAECES (non-serious) with onset May2022, outcome "unknown", described as "Stool odor abnormal / Odor in Stool/Poop Smells Bad"; FEELING COLD (non-serious), outcome "unknown", described as "Feeling cold / Freezing/Had to use Three blankets"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "Productive cough / Coughing up a little bit like had sinus drainage"; INSOMNIA (non-serious), outcome "unknown", described as "Sleep decreased / Averages about four hours of sleep"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm / Arm sore with Humira". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2021) Positive. The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19", "feeling cold / freezing/had to use three blankets", "productive cough / coughing up a little bit like had sinus drainage", "sleep decreased / averages about four hours of sleep" and "stool odor abnormal / odor in stool/poop smells bad" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pain in arm / arm sore with humira" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Acne around my eyes and around my mouth, even on my nose and my fore head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ACNE (non-serious) with onset May2022, outcome "unknown", described as "Acne around my eyes and around my mouth, even on my nose and my fore head".  Additional information: The patient received 2nd Pfizer booster shot 2 month ago. From that day patient got Acne around eyes and around mouth, even on nose and fore head and mentioned that patient never had skin problem in whole life.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.