chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up document received on nov15,contains patient demographics and product information updated
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Patient details received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-Nov-2021 Contains patient identifiers
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-NOV-2021.includes reporter information, patient demographics, dosage information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Nov 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 1, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used). On Nov 1, 2021, product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Nov 15, 2021: patient details added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: there was no excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was no excrusion from freezer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was no excrusion from freezer). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was no excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant Medications details were provided. No treatment Medications details were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Excursion from the freezer; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was temperature excursion from their freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Possible AE; patient not receiving 2nd dose on proper time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Possible AE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient not receiving 2nd dose on proper time) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Myocarditis (had twice, very painful, that she can't get sick for six month), Pericarditis (had twice, very painful, that she can't get sick for six month), Pericardial effusion (6 years ago) and Cardiac operation (6 years ago operated on myocardium area 12 days for pericardium effusion.). Concurrent medical conditions included Lung disease.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient not receiving 2nd dose on proper time). On an unknown date, the patient experienced VACCINATION COMPLICATION (Possible AE). On 11-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient not receiving 2nd dose on proper time) had resolved. At the time of the report, VACCINATION COMPLICATION (Possible AE) outcome was unknown.            No  concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains no new information.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Papule, Pruritus, Urticaria
Clinical narrative: Having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive; Small bumps would pop up, itch like crazy for 15-20 minutes; Small bumps would pop up, itch like crazy for 15-20 minutes; Booster; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered left arm on 21Oct2021 11:00 (at the age of 73 years old) (Lot Number: 30155BA) as dose 3 (booster), single for COVID-19 immunisation. Medical history included none. Patient is not pregnant at time of vaccination. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the BNT162B2, first dose (Batch/Lot No: EL9265) on 01Feb2021, second dose (Batch/Lot No: EN6200) on 23Feb2021, both at the age of 73 years old, in left arm for COVID-19 immunization. The patient experienced having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive on 23Oct2021 08:00, small bumps would pop up, itch like crazy for 15-20 minutes on 23Oct2021 08:00. Clinical course: Received the Pfizer covid 19 booster on 21Oct2021 and two days later started having hives on various parts of her torso: lower back, shoulders, thighs, stomach, and neck. Small bumps would pop up, itch like crazy for 15-20 minutes and then subside leaving a small red hive. Occurred mainly early evening and early morning. This lasted 10 days. Subsided a couple of days after she started taking Benadryl twice daily. She did not have this reaction of hives after either covid shot 1 or 2 that she received in early Feb2021. Her experience was very much like the case reported in the journal Cureos in Sep2021. withheld-chronic-spontaneous-urticaria-after-covid-19-vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: Having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive; Small bumps would pop up, itch like crazy for 15-20 minutes; Small bumps would pop up, itch like crazy for 15-20 minutes; Booster; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered left arm on 21Oct2021 11:00 (at the age of 73 years old) (Lot Number: 30155BA) as dose 3 (booster), single for COVID-19 immunisation. Medical history included none. Patient is not pregnant at time of vaccination. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the BNT162B2, first dose (Batch/Lot No: EL9265) on 01Feb2021, second dose (Batch/Lot No: EN6200) on 23Feb2021, both at the age of 73 years old, in left arm for COVID-19 immunization. The patient experienced having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive on 23Oct2021 08:00, small bumps would pop up, itch like crazy for 15-20 minutes on 23Oct2021 08:00. Clinical course: Received the Pfizer covid 19 booster on 21Oct2021 and two days later started having hives on various parts of her torso: lower back, shoulders, thighs, stomach, and neck. Small bumps would pop up, itch like crazy for 15-20 minutes and then subside leaving a small red hive. Occurred mainly early evening and early morning. This lasted 10 days. Subsided a couple of days after she started taking Benadryl twice daily. She did not have this reaction of hives after either covid shot 1 or 2 that she received in early Feb2021. Her experience was very much like the case reported in the journal Cureos in Sep2021. withheld-chronic-spontaneous-urticaria-after-covid-19-vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy, Blood test, Bone scan, Chest X-ray
Clinical narrative: Her cancer has came back; weak and stayed in bed and couldn't mobilize; weak and stayed in bed and couldn't mobilize; lost 10 pounds in 1.5 weeks; I could not eat; swollen lymph nodes; Nauseous; Depressed; aches and pains and hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: WAB6941) as dose 2, single for COVID-19 immunization at a pharmacy. Medical history included breast cancer female from an unknown date (Breast cancer survivor). Concomitant medication included tamoxifen taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 on 20Aug2021, as 1st dose at 54 years old for COVID-19 immunization. On an unspecified date in 2021, it was reported that her cancer has came back, weak and stayed in bed and couldn't mobilize, lost 10 pounds in 1.5 weeks, could not eat, had swollen lymph nodes, depressed, and had aches and pains and hurt. No treatment was given. The patient also had nauseous on 2021 which prompted emergency room consult and was treated with Zofran. The patient underwent lab tests and procedures which included blood test: unknown results, bone scan: unknown results, chest x-ray: swollen lymph nodes, computerised tomogram (CT): swollen lymph nodes, and Biopsy: negative on unspecified date in 2021, and weight: 165 lbs from 175 lbs (lost 10 pounds I am 165 now because I was 175) in 2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Depression, Eating disorder, Immobile, Lymphadenopathy
Clinical narrative: Her cancer has came back; weak and stayed in bed and couldn't mobilize; weak and stayed in bed and couldn't mobilize; lost 10 pounds in 1.5 weeks; I could not eat; swollen lymph nodes; Nauseous; Depressed; aches and pains and hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: WAB6941) as dose 2, single for COVID-19 immunization at a pharmacy. Medical history included breast cancer female from an unknown date (Breast cancer survivor). Concomitant medication included tamoxifen taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 on 20Aug2021, as 1st dose at 54 years old for COVID-19 immunization. On an unspecified date in 2021, it was reported that her cancer has came back, weak and stayed in bed and couldn't mobilize, lost 10 pounds in 1.5 weeks, could not eat, had swollen lymph nodes, depressed, and had aches and pains and hurt. No treatment was given. The patient also had nauseous on 2021 which prompted emergency room consult and was treated with Zofran. The patient underwent lab tests and procedures which included blood test: unknown results, bone scan: unknown results, chest x-ray: swollen lymph nodes, computerised tomogram (CT): swollen lymph nodes, and Biopsy: negative on unspecified date in 2021, and weight: 165 lbs from 175 lbs (lost 10 pounds I am 165 now because I was 175) in 2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neoplasm malignant, Pain, Weight, Weight decreased
Clinical narrative: Her cancer has came back; weak and stayed in bed and couldn't mobilize; weak and stayed in bed and couldn't mobilize; lost 10 pounds in 1.5 weeks; I could not eat; swollen lymph nodes; Nauseous; Depressed; aches and pains and hurt; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Sep2021 (Batch/Lot Number: WAB6941) as dose 2, single for COVID-19 immunization at a pharmacy. Medical history included breast cancer female from an unknown date (Breast cancer survivor). Concomitant medication included tamoxifen taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 on 20Aug2021, as 1st dose at 54 years old for COVID-19 immunization. On an unspecified date in 2021, it was reported that her cancer has came back, weak and stayed in bed and couldn't mobilize, lost 10 pounds in 1.5 weeks, could not eat, had swollen lymph nodes, depressed, and had aches and pains and hurt. No treatment was given. The patient also had nauseous on 2021 which prompted emergency room consult and was treated with Zofran. The patient underwent lab tests and procedures which included blood test: unknown results, bone scan: unknown results, chest x-ray: swollen lymph nodes, computerised tomogram (CT): swollen lymph nodes, and Biopsy: negative on unspecified date in 2021, and weight: 165 lbs from 175 lbs (lost 10 pounds I am 165 now because I was 175) in 2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: suicidal thoughts; This is a spontaneous report from a contactable other healthcare professional. An 18-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Oct2021 (at the age of 18-years-old) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient stated that she experienced suicidal thoughts for 1 and 1/2 weeks after her first dose, on 15Oct2021; no prior suicidal thoughts experienced prior to administration of first covid vaccine. It was unknown if a treatment was administered for the event. The patient had recovered from the event in Oct2021.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Extreme shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of bnt162b2 (PFIZER COVID19 VACCINE), via an unspecified route of administration, administered in Arm Right at the age of 31-year-old on 01Oct2021 12:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none.  The patient's concomitant medications were not reported. The patient experienced extreme shortness of breath on 02Oct2021 12:00 with outcome of not recovered. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose of bnt162b2 on 01Nov2021 covid-19 immunisation.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: out of breath; blood clots in her lungs; felt a knot on the back of her knee.; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A 79-year-old female patient received the third dose of BNT162B2 (PFIZER COVID VACCINE) via an unspecified route of administration on the left arm on 06Oct2021 (Batch/Lot Number: FF2590; Expiration Date: Unknown) at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included thyroid, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Prior vaccination (within 4 weeks) was none. Years ago, she worked in admissions in a small hospital. Concomitant medication included ongoing levothyroxine for thyroid. The patient previously received the first dose and the second dose of BNT162B2, the first dose on 28Jan2021 (Lot Number: EL9263), the second dose on 16Feb2021 (Lot Number: EN6201), both via an unspecified route of administration as single dose for COVID-19 immunization and experienced a little bit of feeling tired with those. In 2021, the patient was being treated for blood clots in her lungs. A couple of days later, she felt a knot on the back of her knee. She made an appointment on 12Oct2021 with her doctor. Her doctor said he didn't think much of it. Then, when she was walking around on 19Oct2021 she was out of breath. They also did an ultra sound of her legs, and did find a clot where the knot was. She was calling because she figured Pfizer is still doing research. She is pro vaccine, and always promotes it. It is wonderful. This could or could not be related, but she wanted to report just in case. She did not have a prescribing doctor. She just made an appointment at the pharmacy. She got out of the hospital on the evening of the 22Oct2021. She has another week of Lovenox, and then she is going on Eliquis for 6 months. She has seen a hematologist. She is still on oxygen at home at night. The handwriting was so tiny. Relevant tests included list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI). They did a CT scan, ultra sound, echocardiogram, and EKG. Everything looked fine. The only medication she takes is for her thyroid. She takes Levothyroxine 50mcg. She knows Pfizer was working 24 hours a day to get the vaccine ready. She is very thankful. She is getting better everyday. The events resulted in emergency room and physician office. The events resulted in hospitalization from 19Oct2021 to 22Oct2021. Investigation assessment was none. The outcome of   No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Ultrasound scan
Clinical narrative: out of breath; blood clots in her lungs; felt a knot on the back of her knee.; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A 79-year-old female patient received the third dose of BNT162B2 (PFIZER COVID VACCINE) via an unspecified route of administration on the left arm on 06Oct2021 (Batch/Lot Number: FF2590; Expiration Date: Unknown) at the age of 79-year-old as single dose for COVID-19 immunization. Medical history included thyroid, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Prior vaccination (within 4 weeks) was none. Years ago, she worked in admissions in a small hospital. Concomitant medication included ongoing levothyroxine for thyroid. The patient previously received the first dose and the second dose of BNT162B2, the first dose on 28Jan2021 (Lot Number: EL9263), the second dose on 16Feb2021 (Lot Number: EN6201), both via an unspecified route of administration as single dose for COVID-19 immunization and experienced a little bit of feeling tired with those. In 2021, the patient was being treated for blood clots in her lungs. A couple of days later, she felt a knot on the back of her knee. She made an appointment on 12Oct2021 with her doctor. Her doctor said he didn't think much of it. Then, when she was walking around on 19Oct2021 she was out of breath. They also did an ultra sound of her legs, and did find a clot where the knot was. She was calling because she figured Pfizer is still doing research. She is pro vaccine, and always promotes it. It is wonderful. This could or could not be related, but she wanted to report just in case. She did not have a prescribing doctor. She just made an appointment at the pharmacy. She got out of the hospital on the evening of the 22Oct2021. She has another week of Lovenox, and then she is going on Eliquis for 6 months. She has seen a hematologist. She is still on oxygen at home at night. The handwriting was so tiny. Relevant tests included list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI). They did a CT scan, ultra sound, echocardiogram, and EKG. Everything looked fine. The only medication she takes is for her thyroid. She takes Levothyroxine 50mcg. She knows Pfizer was working 24 hours a day to get the vaccine ready. She is very thankful. She is getting better everyday. The events resulted in emergency room and physician office. The events resulted in hospitalization from 19Oct2021 to 22Oct2021. Investigation assessment was none. The outcome of   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Electrocardiogram, Pyrexia
Clinical narrative: My CRPs are super high; hs-CRP and the regular CRP are super high; My CRP, regular CRP is 37 and the hs-CRP is 36.6; It is still high; CRP is 18 and the hs-CRP is 17.4; Fever; This is a spontaneous report from a contactable consumer (patient). This 68-year-old male patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm on 17Oct2021 at the age of 68-year-old for covid-19 immunisation. The first and second dose of Covid-19 vaccine were on an unspecified date, primary Immunization series complete but unknown manufacturer. Medical history included hypertension. Concomitant medication included hypertensive drug. Patient received the third dose on 17Oct2021 and then on 30Oct2021, for a while patient had been experiencing fever at night. So, he run test because he worked in the lab and his CRPs were super high on 30Oct2021. He had hs-CRP and the regular CRP were super high. So, he went to the doctor on 05Nov2021 and doctor told him, it was very unusual because if it was a side effect, it had to be immediate but it took a while for this if it was a side effect but doctor told me and he didn't give him anything and he told him to call Pfizer to report this and he thought that this was the adverse reaction, a delayed one. On 03Nov2021, regular CRP was 37 and the hs-CRP was 36.6. Then he repeated the test (in 2021) and now it went a lot down but it was still high, the CRP was 18 and the hs-CRP was 17.4. EKG was normal in 2021. Patient took TYLENOL because he still had some little fever at night but it was okay now. He took 50 (not clarified) and that was only once in a day when he had fever like symptoms. There was no treatment received for CRP increased. The events required physician office visit. The outcome of events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: tinnitus; achy; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm on 08Feb2021 09:30 (Batch/Lot Number: EN5318) as dose 2, single for covid-19 immunization. Medical history included bronchitis from 29Nov2019 to 05Jan2020 (After the illness and believe it could of been Covid), breast cancer from Jun1999 to an unknown date (Radiation ended in Jul), thyroid cancer from Feb1986 to an unknown date (Cancer free), radiation from an unknown date and unknown if ongoing (Radiation ended in Jul). There were no concomitant medications. The patient received bnt162b2 (BNT162B2), intramuscular, administered in right arm on 18Jan2021 08:00 (Batch/Lot Number: EL1283) as dose 1, single for covid-19 immunization and experienced feeling unwell, fever, sore throat, flu like symptoms. The patient experienced tinnitus in Mar2021 with outcome of not recovered, achy in 2021 with outcome of recovered on an unspecified date in 2021. Second dose had minimal side effects achy for 6 hrs. The event tinnitus was reported as serious per medically significant. The adverse event required visit to physician office. No treatment received. Vaccination facility type was hospital. No prior vaccinations (within 4 weeks). No relevant test.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112933 Same reporter/ patient, different dose/AEs.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myocardial infarction, SARS-CoV-2 test, Thrombosis
Clinical narrative: Heart Attack; most likely a blood clot; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient).   A 62-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 13Aug2021 13:00 at 62-years-old (Batch/Lot Number: FA7485) as DOSE 1, SINGLE; via an unspecified route of administration, administered in Arm Right on 08Oct2021 13:00 at 62-years-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included No - Healthy. Facility type Vaccine: Pharmacy or Drug Store. No covid prior to vaccination, was covid tested post vaccination. Concomitant medication included trazodone. The patient previously took demerol and experienced Allergy. The patient experienced heart attack most likely a blood clot (hospitalization, life threatening) on 16Sep2021 01:00 with outcome of recovered with sequelae, inappropriate schedule of vaccine administered on 08Oct2021 13:00 with outcome of unknown. The patient was hospitalized for 2 days. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment included Angioplasty, medicine. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Sep2021.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (parent). A 15-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was a healthy person and had 7% body fat and very athletic. The patient experienced severe anaphylactic reaction. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: Severe Parosmia/smell changed drastically; taste and smell changed drastically, all foods tasted and smelled of rotting meat and garbage; Fast food still tastes very chemically and onion are still rotten; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) as dose 2, single at the age of 23 years old for COVID-19 immunisation. No medical history. No known allergies. Concomitant medications were not reported. Historic vaccine was first dose of bnt162b2 (lot number: EN6199) administered in right arm received on 10Mar2021 11:00 as dose 1, single at the age of 23 years old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced severe parosmia, taste and smell changed drastically, all foods tasted and smelled of rotting meat and garbage, fast food still tasted very chemically and onion were still rotten on 10Apr2021. Events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment received. No Covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab BinaxNOW: negative on 10Sep2021. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; Loss of appetite; stomach pains; This is a solicited report based on information received by Pfizer from AbbVie (Mfr. Control No.: 21K-163-4143656-00).   A contactable consumer (patient) reported that a 14-years-old female patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose (Citrate free), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe pediatric crohn's disease. It was unknown if patient was enrolled in a COVID-19 vaccine trial. She received dose of COVID-19 vaccine manufactured by Pfizer BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded. The patient medical history and concomitant medications were not reported. The patient experienced covid-19 on an unspecified date with outcome of recovered, loss of appetite (decreased appetite/ appetite lost) on an unspecified date with outcome of unknown, stomach pains (abdominal pain upper) on an unspecified date with outcome of recovering.  The action taken in response to the events for adalimumab was permanently withdrawn. Case was reported as non-serious. The reporter's causality for the events with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the events with PFIZER BIONTECH COVID-19 VACCINE was possible.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: The events of drug ineffective, suspected COVID-19, decreased appetite and abdominal pain upper are related to the suspect product BNT162B2 based on plausible temporal relationship. The confounding factor for decreased appetite and abdominal pain upper is underlying medical condition of Crohn's disease.
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Mass, Pruritus, Urticaria
Clinical narrative: welt; itchy; lump under skin; This is a spontaneous report from a contactable consumer or other non hcp.   A 75-years-old patient of an unspecified gender received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA SOLUTION FOR INJECTION (Batch/Lot Number: EP9534), dose 2 intramuscularly, administered in Arm right on 17Mar2021 15:05 as dose 2, single for covid-19 immunisation. Medical history included, osteoporosis, hypertonic bladder. Concomitant medication(s) included tolterodine (TOLTERODINE) taken for hypertonic bladder from 2000 and ongoing; raloxifene (RALOXIFENE) taken for osteoporosis from Sep2020 to 17Mar2021.Historical vaccine included BNT162B2 PFIZER BIOTECH MRNA SOLUTION FOR INJECTION (Batch/Lot Number: EN6203), dose 1 intramuscularly, administered in Arm left on 24Feb2021 14:35 as dose 1, single for covid-19 immunisation.The patient previously took Levaquin, cipro and Benadryl, polymyxin b sulphate experienced hypersensitivity. It was reported that, on 02Mar2021 08:30, The patient experienced welt, Itchy, lump under skin with outcome of not recovered.The patient underwent lab tests and procedures which included c-reactive protein: normal on 23Feb2021 <1 , full blood count: normal on 23Feb2021. Therapeutic measures were taken as a result of welt (urticaria), itchy (pruritus), lump under skin (mass).  Regardless, symptoms first recorded 0.3 Mar2021. Ongoing daily (with exception of 5 to 6 days) until 11Jul2021. No hives since then. I'm considering having the booster shot so I would like some guidance about possibility of first doses causing the hives.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Pain, Product administration error
Clinical narrative: had a "golf ball sized" bubble or lump appear on her arm where she received the injection; administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose; really tired, like too tired to play with my kids because I did not even want to get out of the chair; I did not even want to get out of the chair; some body aches; chills; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID19 SOLUTION FOR INJECTION), dose 1 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, on 2021, The patient experienced had a "golf ball sized" bubble or lump appear on her arm where she received the injection administration error from the injection/does not know if she received the full first dose of the vaccine or if it would be counted as a valid dose, really tired, like too tired to play with my kids because did not even want to get out of the chair on,  did not even want to get out of the chair, some body aches, chills  with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.