chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; On 15Mar2021, he received 1st doseCovid-19 Vaccine/15May2021, patient received 2nd dose Covid-19 Vaccine;   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-163-4245037-00.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 15May2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1156743) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Route of Admin: Intra-muscular), administration date: 15Mar2021, when the patient was 22 years old, for COVID-19 Vaccination, reaction(s): "COVID", "COVID". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15May2021, outcome "unknown", described as "On 15Mar2021, he received 1st doseCovid-19 Vaccine/15May2021, patient received 2nd dose Covid-19 Vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for adalimumab was unknown.  Additional Information: an event of non-serious Covid with Humira (adalimumab). On an unknown date, the patient experienced covid. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. On 15Mar2021, he received 1st dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. On 05May2021, patient received 2nd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. On 05Sep2021, patient received 3rd dose Covid-19 Vaccine manufactured by Pfizer/BioNTech. Causality for HUMIRA (ADALIMUMAB). The reporters causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility. Causality was reported as, for HUMIRA(ADALIMUMAB): COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): No reasonable possibility. For PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): COVID-19 (COVID-19) Causality as per reporter (Drug/Vaccine): Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 22.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: On an unknown date, the patient experienced covid.; On an unknown date, the patient experienced covid.; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4245037-00.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Sep2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Route of Admin: Intramuscular), administration date: 15Mar2021, when the patient was 22 years old, for COVID-19 Immunization, reaction(s): "COVID-19", "COVID-19"; Bnt162b2 (2nd dose, Route of Admin: Intramuscular), administration date: 15May2021, when the patient was 22 years old, for COVID-19 Immunization, reaction(s): "COVID-19", "COVID-19", "On 15Mar2021, he received 1st doseCovid-19 Vaccine/05May2021, patient received 2nd dose Covid-19 Vaccine".  The following information was reported: COVID-19 (medically significant), outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "On an unknown date, the patient experienced covid.". The action taken for adalimumab was unknown. The reporter considered "on an unknown date, the patient experienced covid." related to bnt162b2.  Causality for HUMIRA (ADALIMUMAB)  The reporters causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)  The reporters causality for the event(s) of COVID with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN)  was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events  COVID-19, DRUG INEFFECTIVE and the suspect drug BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Physician) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4241744-00 (AbbVie).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3, (booster) single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen subcutaneous since Sep2021 (Batch/Lot number: unknown) and second regimen since 07Jan2022 (ongoing) (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Hospitalized", start date: Mar2021 (unspecified if ongoing); "Confusion" (unspecified if ongoing); "Did not feel right" (unspecified if ongoing); "Cellulitis", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Intra-muscular), administration date: Feb2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Cellulitis"; Bnt162b2 (Dose 2, Intra-muscular), administration date: Feb2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Cellulitis". The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "Heart attack". The patient was hospitalized for myocardial infarction (start date: 10Jan2022, discharge date: 11Jan2022, hospitalization duration: 1 day(s)). The action taken for risankizumab was dosage not changed.  Reporter's causality for Skyrizi for the event(s) of heart attack was not provided and reporter causality for pfizer biontech COVID-19 for the event(s) of heart attack was possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between all the reported  event myocardial infarction 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: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive.  Clinical information: No underlying conditions. She completed the 2 dose primary series on schedule and received her booster dose 6 months later in early Dec2021. She tested positive for Covid-19 on 20Jan2022 after experiencing symptoms and took a at home antigen rapid test.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200176387 same reporter/patient/product, dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Disturbance in attention
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive.  Clinical information: No underlying conditions. She completed the 2 dose primary series on schedule and received her booster dose 6 months later in early Dec2021. She tested positive for Covid-19 on 20Jan2022 after experiencing symptoms and took a at home antigen rapid test.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200176387 same reporter/patient/product, dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: difficulty focusing and clarity.; The initial positive test brings about a lot of anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, I completed the 2 dose primary series on schedule), for Covid-19 immunization, reaction(s): "tested positive for Covid-19", "tested positive for Covid-19"; Bnt162b2 (Dose:2, I completed the 2 dose primary series on schedule), for COVID-19 Immunization, reaction(s): "tested positive for Covid-19", "tested positive for Covid-19". The following information was reported: DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "difficulty focusing and clarity."; ANXIETY (non-serious), outcome "unknown", described as "The initial positive test brings about a lot of anxiety". Additional information The reason for the patient's delay in reporting personal adverse event was a result of symptoms from illness with COVID-19. Along with physical symptoms and patient also experienced difficulty focusing and clarity. The initial positive test brings about a lot of anxiety and it did not cross patient's mind to report.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145615 same reporter/patient/product, dose
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Disturbance in attention
Clinical narrative: difficulty focusing and clarity.; The initial positive test brings about a lot of anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, I completed the 2 dose primary series on schedule), for Covid-19 immunization, reaction(s): "tested positive for Covid-19", "tested positive for Covid-19"; Bnt162b2 (Dose:2, I completed the 2 dose primary series on schedule), for COVID-19 Immunization, reaction(s): "tested positive for Covid-19", "tested positive for Covid-19". The following information was reported: DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "difficulty focusing and clarity."; ANXIETY (non-serious), outcome "unknown", described as "The initial positive test brings about a lot of anxiety". Additional information The reason for the patient's delay in reporting personal adverse event was a result of symptoms from illness with COVID-19. Along with physical symptoms and patient also experienced difficulty focusing and clarity. The initial positive test brings about a lot of anxiety and it did not cross patient's mind to report.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200145615 same reporter/patient/product, dose
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rheumatoid arthritis, Swelling
Clinical narrative: Rheumatoid arthritis flare up; Swelling; Pain aggravated;  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-163-4242523-00 (AbbVie).  An adult female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from 2020 (Batch/Lot number: unknown) to 2021 at citrate free and second regimen subcutaneous since Dec2021 (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; SWELLING (non-serious), outcome "recovering", described as "Swelling"; PAIN (non-serious), outcome "recovering", described as "Pain aggravated". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of swelling increased, pain increased and flare up of rheumatoid arthritis joint pain with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for BNT162B2: The reporter's causality for the event(s) of swelling increased and pain increased with BNT162B2 was not reported. Flare up of rheumatoid arthritis joint pain with BNT162B2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - Rheumatoid arthritis,  pain, swelling, and the suspect drug "BNT162B2" cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hip surgery, Therapeutic product effect incomplete
Clinical narrative: Joint pain; Hip surgery; Drug effect incomplete; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240194-00.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and intramuscular, administration date 15Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous from Jan2021 (Batch/Lot number: unknown) to 11Jun2021 and second regimen subcutaneous since 2021 (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HIP SURGERY (medically significant) with onset 2021, outcome "unknown", described as "Hip surgery"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 2021, outcome "unknown", described as "Drug effect incomplete"; ARTHRALGIA (non-serious) with onset 02Oct2021, outcome "unknown", described as "Joint pain". The action taken for adalimumab was dosage permanently withdrawn.  Causality of drug Humira (Drug/Vaccine) as per Mfr. for event Hip surgery, Drug effect incomplete and Joint pain was No reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product 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 in the case report, a possible causal relationship between reported event and suspect product BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable other HCP (nurse). A child patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced ineffective drug/child was affected (medically significant) and COVID-19 (medically significant), with outcome of unknown. The lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Based on the limited information provided, the causal association between the reported events and the suspect drug, cannot be excluded.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Colonoscopy, Constipation, Inappropriate schedule of product administration
Clinical narrative: severe constipation 02 days; inappropriate schedule of vaccine administered ( dose 1 on 01Mar2021/ dose 2 on 21Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Apr2021 13:00 (Lot number: ER8736) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure", start date: Jul2014 (ongoing); "Depression", start date: Aug2018 (ongoing); "Anxiety", start date: Aug2018 (ongoing); "Diverticulosis", start date: Jan2016 (ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN HYDROCHLOROTHIAZIDE AKRIKHIN taken for blood pressure abnormal (ongoing); WELLBUTRIN taken for depression, anxiety (ongoing); PRISTIQ taken for depression, anxiety (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 4pm, Anatomical site of injection: Left Arm, Route of administration: Intramuscular, Batch/lot number: ER8737), administration date: 21Mar2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "severe constipation". The following information was reported: CONSTIPATION (medically significant) with onset 23Apr2021, outcome "recovered", described as "severe constipation 02 days"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Apr2021, outcome "unknown", described as "inappropriate schedule of vaccine administered ( dose 1 on 01Mar2021/ dose 2 on 21Apr2021". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Jul2014) high; colonoscopy: (Jan2016) unknown result. Therapeutic measures were taken as a result of constipation. Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Placental disorder, Stillbirth
Clinical narrative: Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 39 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ACYCLOVIR. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, life threatening) with onset 27Jul2021 09:00, outcome "recovered", PLACENTAL DISORDER (hospitalization, life threatening), STILLBIRTH (hospitalization, life threatening) all with onset 03Aug2021 09:00, outcome "recovered" and all described as "Stillbirth-child died. Infection of the placenta but not in blood.". The patient was hospitalized for maternal exposure during pregnancy, placental disorder, stillbirth (hospitalization duration: 1 day(s)). The event "stillbirth-child died. infection of the placenta but not in blood.", "stillbirth-child died. infection of the placenta but not in blood." and "stillbirth-child died. infection of the placenta but not in blood." was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, placental disorder, stillbirth. Additional information: The patient had no other vaccine in four weeks and had no covid prior vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200151417 Same reporter/drug, baby case
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 39 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ACYCLOVIR. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, life threatening) with onset 27Jul2021 09:00, outcome "recovered", PLACENTAL DISORDER (hospitalization, life threatening), STILLBIRTH (hospitalization, life threatening) all with onset 03Aug2021 09:00, outcome "recovered" and all described as "Stillbirth-child died. Infection of the placenta but not in blood.". The patient was hospitalized for maternal exposure during pregnancy, placental disorder, stillbirth (hospitalization duration: 1 day(s)). The event "stillbirth-child died. infection of the placenta but not in blood.", "stillbirth-child died. infection of the placenta but not in blood." and "stillbirth-child died. infection of the placenta but not in blood." was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, placental disorder, stillbirth. Additional information: The patient had no other vaccine in four weeks and had no covid prior vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200151417 Same reporter/drug, baby case
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amniotic fluid volume, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia
Clinical narrative: Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 39 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ACYCLOVIR. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, life threatening) with onset 27Jul2021 09:00, outcome "recovered", PLACENTAL DISORDER (hospitalization, life threatening), STILLBIRTH (hospitalization, life threatening) all with onset 03Aug2021 09:00, outcome "recovered" and all described as "Stillbirth-child died. Infection of the placenta but not in blood.". The patient was hospitalized for maternal exposure during pregnancy, placental disorder, stillbirth (hospitalization duration: 1 day(s)). The event "stillbirth-child died. infection of the placenta but not in blood.", "stillbirth-child died. infection of the placenta but not in blood." and "stillbirth-child died. infection of the placenta but not in blood." was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, placental disorder, stillbirth. Additional information: The patient had no other vaccine in four weeks and had no covid prior vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200151417 Same reporter/drug, baby case
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Stillbirth, Ultrasound foetal abnormal, Uterine contractions during pregnancy
Clinical narrative: Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; Stillbirth-child died. Infection of the placenta but not in blood.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 39 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; ACYCLOVIR. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (hospitalization, life threatening) with onset 27Jul2021 09:00, outcome "recovered", PLACENTAL DISORDER (hospitalization, life threatening), STILLBIRTH (hospitalization, life threatening) all with onset 03Aug2021 09:00, outcome "recovered" and all described as "Stillbirth-child died. Infection of the placenta but not in blood.". The patient was hospitalized for maternal exposure during pregnancy, placental disorder, stillbirth (hospitalization duration: 1 day(s)). The event "stillbirth-child died. infection of the placenta but not in blood.", "stillbirth-child died. infection of the placenta but not in blood." and "stillbirth-child died. infection of the placenta but not in blood." was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. Therapeutic measures were not taken as a result of maternal exposure during pregnancy, placental disorder, stillbirth. Additional information: The patient had no other vaccine in four weeks and had no covid prior vaccination. The patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200151417 Same reporter/drug, baby case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Severe pain in left arm; Severe pain in left arm that radiated to neck and shoulder; Severe pain in left arm that radiated to neck and shoulder; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 14:00 (Lot number: FH8027) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Dec2021, outcome "recovering", described as "Severe pain in left arm"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 03Dec2021, outcome "recovering" and all described as "Severe pain in left arm that radiated to neck and shoulder". The events "severe pain in left arm", "severe pain in left arm that radiated to neck and shoulder" and "severe pain in left arm that radiated to neck and shoulder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, neck pain, arthralgia.  Additional information: Patient did not receive any other vaccine in four weeks of vaccination and other medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination, underwent COVID nasal swab test with negative result.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, SARS-CoV-2 antibody test
Clinical narrative: anaphylaxis described as severe reactions; Feeling poorly/flat out; 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): 20210356466(5) ), 20210929143.  A 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing), notes: she had a cancer, Cancer (Cancer) (Unknown) (Continuing: Yes); "Vaccine Sensitivity" (ongoing), notes: Vaccine Sensitivity (Hypersensitivity) (Unknown) (Continuing: Yes). The patient's concomitant medications were not reported.  The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 27Mar2021, outcome "not recovered", described as "anaphylaxis described as severe reactions"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling poorly/flat out". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive.  The reporter's assessment of the causal relationship of the events with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event anaphylactic reactions cannot be totally excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Dizziness, Immunisation
Clinical narrative: Positive for covid; Positive for covid; cough; sore throat; dizziness; diarrhea; Booster; Off Label; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244366-00 (AbbVie).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150528). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 01Aug2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 01Aug2021, outcome "unknown", described as "Off Label"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Positive for covid"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "sore throat"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive. The action taken for upadacitinib was unknown. It was mentioned that the patient had fever for three days, cough, sore throat, dizziness and diarrhea.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality reported for suspect Rinvoq was not reported for COVID-19  and dizziness. Causality reported for Pfizer Biontech Covid-19 Vaccine was possible for COVID-19  and dizziness.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive for covid; Positive for covid; cough; sore throat; dizziness; diarrhea; Booster; Off Label; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4244366-00 (AbbVie).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150528). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant) with onset 01Aug2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 01Aug2021, outcome "unknown", described as "Off Label"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "unknown" and all described as "Positive for covid"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "sore throat"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "dizziness"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive. The action taken for upadacitinib was unknown. It was mentioned that the patient had fever for three days, cough, sore throat, dizziness and diarrhea.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality reported for suspect Rinvoq was not reported for COVID-19  and dizziness. Causality reported for Pfizer Biontech Covid-19 Vaccine was possible for COVID-19  and dizziness.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Cancer pain, Hepatic mass, Intestinal mass, Malignant peritoneal neoplasm
Clinical narrative: Peritoneal surface disease; Cancer pain in testes/had cancer cells; Mass in liver/might be in the colon; Mass in liver/might be in the colon; 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-163-4246137-00 (AbbVie).  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 14Feb2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single and intramuscular, administration date 24Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALIGNANT PERITONEAL NEOPLASM (medically significant), outcome "not recovered", described as "Peritoneal surface disease"; CANCER PAIN (medically significant), outcome "unknown", described as "Cancer pain in testes/had cancer cells"; INTESTINAL MASS (non-serious), HEPATIC MASS (non-serious), outcome "unknown" and all described as "Mass in liver/might be in the colon". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporters causality for the event(s) of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells un-known onset, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon unknown onset was not provided. AbbVie opinion is that the events of peritoneal surface disease cancer pain in testes/had cancer cells unknown onset, peritoneal surface disease cancer pain in testes/had cancer cells unknown on-set, mass in liver/might be in the colon unknown onset and mass in liver/might be in the colon un-known onset are not assessable.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) of Peritoneal carcinoma, Cancer pain, Large intestine mass, Hepatic mass was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events malignant peritoneal neoplasm and cancer pain and the suspect drug BNT162B2.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Fatigue, Headache, Staphylococcal infection
Clinical narrative: Cellulitis; Fatigue; Minor headache; Methicillin resistant Staphylococcus aureus; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246636-00.  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single and intramuscular, administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Minor headache"; STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Methicillin resistant Staphylococcus aureus". The patient underwent the following laboratory tests and procedures: staphylococcal infection: unknown, notes: Unknown. The action taken for adalimumab was unknown and for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) Action(s) taken with drug: Drug discontinued.  Additional information: Clinical course was reported as On unknown dates, the patient experienced fatigue after COVID vaccine, cellulitis, minor headache after COVID vaccine and methicillin resistant staphylococcus aureus. pfizer biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect. Event abates after stopping drug was reported as N/A (not specified) for HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE. On 18Oct2021, patient received third booster dose, Intramuscular COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Causality: The reporter's causality for HUMIRA(ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was not reported for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per available information and temporal association, the causal association between the event and the suspect drug cannot be excluded.