chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; J&J vaccine dose: 1; J&J vaccine dose: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2021 as dose 2 (booster), single (Lot number: FH8020) and on 16Sep2022 as dose 3 (booster), single (Lot number: GJ2524) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 23Mar2021 as dose 1, single (Lot number: 1808609) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "bipolar disorder (1)" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergies to cats" (unspecified if ongoing); "allergies to dogs" (unspecified if ongoing); "allergies to horses" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE HCL; ADDERALL; LAMOTRIGINE; BUDESONIDE nasal; TRELEGY ELLIPTA; AZELASTINE HYDROCHLORIDE; NORETHINDRONE ACETATE; EMGALITY [GALCANEZUMAB]. Past drug history included: Verapamil, reaction(s): "Known allergies: Allergic to verapamil". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "J&J vaccine dose: 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: 12 days after my initial positive test I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details, Treatment start date: 26Sep2022, Treatment stop date: 30Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: ew0162), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: fe3590) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies : amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2weeks. The patient received the COVID 19 Treatment, brand=paxlovid, treatment start date=06oct2022 and lot number=gc0603. The Known allergies was amoxicillin.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was unknown about other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: lower inner arm was very itchy; turned into a hives and then a wheel; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 84 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EK9231), administration date: 22Jan2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Lot: EL9269), administration date: 13Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 3, Lot: FH8028), administration date: 09Nov2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (Dose: 4, Lot: FJ4991), administration date: 23Jun2022, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "lower inner arm was very itchy"; URTICARIA (non-serious) with onset 2022, outcome "unknown", described as "turned into a hives and then a wheel".  Additional information: Patient had her injection yesterday and her lower inner arm was very itchy and lasted a short time and turned into a hives and then a wheel a couple of hours later. She had no other symptoms no shortness of breath or anything else and Patient was fine today the wheel has turned into a raised red welt and can be itchy. Caller then proceeds to states that she worked in a hospital for many years and started at an allergy department many years ago. She knows what a hive looks like. But it is usually more than one. This is unusual. There no relevant test. There are no family medical history.Prior to vaccination patient did not receive any other vaccine within 4weeks.It is only one hive and it was on the same arm just seems like it was related to the vaccine. She is just really concerned if it would be worse next time.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: lower inner arm was very itchy; turned into a hives and then a wheel; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 84 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EK9231), administration date: 22Jan2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Lot: EL9269), administration date: 13Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 3, Lot: FH8028), administration date: 09Nov2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (Dose: 4, Lot: FJ4991), administration date: 23Jun2022, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "lower inner arm was very itchy"; URTICARIA (non-serious) with onset 2022, outcome "unknown", described as "turned into a hives and then a wheel".  Additional information: Patient had her injection yesterday and her lower inner arm was very itchy and lasted a short time and turned into a hives and then a wheel a couple of hours later. She had no other symptoms no shortness of breath or anything else and Patient was fine today the wheel has turned into a raised red welt and can be itchy. Caller then proceeds to states that she worked in a hospital for many years and started at an allergy department many years ago. She knows what a hive looks like. But it is usually more than one. This is unusual. There no relevant test. There are no family medical history.Prior to vaccination patient did not receive any other vaccine within 4weeks.It is only one hive and it was on the same arm just seems like it was related to the vaccine. She is just really concerned if it would be worse next time.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: lower inner arm was very itchy; turned into a hives and then a wheel; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 84 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Lot: EK9231), administration date: 22Jan2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 2, Lot: EL9269), administration date: 13Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (Dose: 3, Lot: FH8028), administration date: 09Nov2021, when the patient was 83-year-old, for Covid-19 immunization; BNT162b2 (Dose: 4, Lot: FJ4991), administration date: 23Jun2022, when the patient was 84-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "lower inner arm was very itchy"; URTICARIA (non-serious) with onset 2022, outcome "unknown", described as "turned into a hives and then a wheel".  Additional information: Patient had her injection yesterday and her lower inner arm was very itchy and lasted a short time and turned into a hives and then a wheel a couple of hours later. She had no other symptoms no shortness of breath or anything else and Patient was fine today the wheel has turned into a raised red welt and can be itchy. Caller then proceeds to states that she worked in a hospital for many years and started at an allergy department many years ago. She knows what a hive looks like. But it is usually more than one. This is unusual. There no relevant test. There are no family medical history.Prior to vaccination patient did not receive any other vaccine within 4weeks.It is only one hive and it was on the same arm just seems like it was related to the vaccine. She is just really concerned if it would be worse next time.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Blood creatinine, Blood lactate dehydrogenase, Blood lactic acid, Blood pressure measurement
Clinical narrative: COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations; COVID-19; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoker" (unspecified if ongoing); "vasculitis" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing), notes: on 4-5L of oxygen; "nausea" (unspecified if ongoing), notes: for 2 days; "fever" (unspecified if ongoing), notes: for 2 days. Concomitant medication(s) included: AZATHIOPRINE; PREDNISONE; NINTEDANIB; IMMUNOGLOBULIN I.V. Past drug history included: Rituximab for interstitial lung disease, notes: 1000 mg x 2 doses every 6 months with last infusion one month prior to presentation. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown", described as "COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: positive; positive; positive; Blood creatinine: normal; Blood lactate dehydrogenase: 318 IU/l, notes: elevated; Blood lactic acid: 3.5 mmol/L, notes: elevated; Blood pressure measurement: normotensive; Body temperature: afebrile; Carbon dioxide: 34; Chest X-ray: patchy filling opacities and low lung volumes; Forced expiratory volume: 1.28 L, notes: 39% predicted; Forced vital capacity: 1.60 L, notes: 37% predicted; Haemoglobin: normal; Heart rate: 110, notes: Unit: BPM; Exam: notable for a cough, wheezing, and tachypnea; Platelet count: normal; Pulmonary function test: unchanged; SARS-CoV-2 test: positive; White blood cell count: 5.3 x10 3/mm3. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Carbon dioxide, Chest X-ray, Forced expiratory volume
Clinical narrative: COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations; COVID-19; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoker" (unspecified if ongoing); "vasculitis" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing), notes: on 4-5L of oxygen; "nausea" (unspecified if ongoing), notes: for 2 days; "fever" (unspecified if ongoing), notes: for 2 days. Concomitant medication(s) included: AZATHIOPRINE; PREDNISONE; NINTEDANIB; IMMUNOGLOBULIN I.V. Past drug history included: Rituximab for interstitial lung disease, notes: 1000 mg x 2 doses every 6 months with last infusion one month prior to presentation. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown", described as "COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: positive; positive; positive; Blood creatinine: normal; Blood lactate dehydrogenase: 318 IU/l, notes: elevated; Blood lactic acid: 3.5 mmol/L, notes: elevated; Blood pressure measurement: normotensive; Body temperature: afebrile; Carbon dioxide: 34; Chest X-ray: patchy filling opacities and low lung volumes; Forced expiratory volume: 1.28 L, notes: 39% predicted; Forced vital capacity: 1.60 L, notes: 37% predicted; Haemoglobin: normal; Heart rate: 110, notes: Unit: BPM; Exam: notable for a cough, wheezing, and tachypnea; Platelet count: normal; Pulmonary function test: unchanged; SARS-CoV-2 test: positive; White blood cell count: 5.3 x10 3/mm3. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: M
Vaccine: COVID19
Symptoms: Forced vital capacity, Haemoglobin, Heart rate, Investigation, Platelet count
Clinical narrative: COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations; COVID-19; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoker" (unspecified if ongoing); "vasculitis" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing), notes: on 4-5L of oxygen; "nausea" (unspecified if ongoing), notes: for 2 days; "fever" (unspecified if ongoing), notes: for 2 days. Concomitant medication(s) included: AZATHIOPRINE; PREDNISONE; NINTEDANIB; IMMUNOGLOBULIN I.V. Past drug history included: Rituximab for interstitial lung disease, notes: 1000 mg x 2 doses every 6 months with last infusion one month prior to presentation. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown", described as "COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: positive; positive; positive; Blood creatinine: normal; Blood lactate dehydrogenase: 318 IU/l, notes: elevated; Blood lactic acid: 3.5 mmol/L, notes: elevated; Blood pressure measurement: normotensive; Body temperature: afebrile; Carbon dioxide: 34; Chest X-ray: patchy filling opacities and low lung volumes; Forced expiratory volume: 1.28 L, notes: 39% predicted; Forced vital capacity: 1.60 L, notes: 37% predicted; Haemoglobin: normal; Heart rate: 110, notes: Unit: BPM; Exam: notable for a cough, wheezing, and tachypnea; Platelet count: normal; Pulmonary function test: unchanged; SARS-CoV-2 test: positive; White blood cell count: 5.3 x10 3/mm3. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test, SARS-CoV-2 test, Vaccination failure, White blood cell count
Clinical narrative: COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations; COVID-19; This is a literature report.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoker" (unspecified if ongoing); "vasculitis" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing), notes: on 4-5L of oxygen; "nausea" (unspecified if ongoing), notes: for 2 days; "fever" (unspecified if ongoing), notes: for 2 days. Concomitant medication(s) included: AZATHIOPRINE; PREDNISONE; NINTEDANIB; IMMUNOGLOBULIN I.V. Past drug history included: Rituximab for interstitial lung disease, notes: 1000 mg x 2 doses every 6 months with last infusion one month prior to presentation. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), outcome "unknown", described as "COVID-19 pneumonia requiring inpatient hospitalization despite three COVID mRNA vaccinations"; COVID-19 (hospitalization, medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: positive; positive; positive; Blood creatinine: normal; Blood lactate dehydrogenase: 318 IU/l, notes: elevated; Blood lactic acid: 3.5 mmol/L, notes: elevated; Blood pressure measurement: normotensive; Body temperature: afebrile; Carbon dioxide: 34; Chest X-ray: patchy filling opacities and low lung volumes; Forced expiratory volume: 1.28 L, notes: 39% predicted; Forced vital capacity: 1.60 L, notes: 37% predicted; Haemoglobin: normal; Heart rate: 110, notes: Unit: BPM; Exam: notable for a cough, wheezing, and tachypnea; Platelet count: normal; Pulmonary function test: unchanged; SARS-CoV-2 test: positive; White blood cell count: 5.3 x10 3/mm3. Therapeutic measures were taken as a result of covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8734), in right arm, on 22Apr2021 as dose 2, single (Lot number: EW0171), in right arm, on 06Dec2021 as dose 3 (booster), single (Lot number: FD0809), in right arm and on 16May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "seizure disorder" (unspecified if ongoing); "vestibular migraine" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included (other medication in 2weeks): MAGNESIUM; VITAMIN D3; RIBOFLAVIN; TUMERIC. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested negative twice after finished with Paxlovid; Negative, notes: Tested negative twice after finished with Paxlovid; Positive, notes: Then positive 5 days after finishing last Paxlovid dose. Therapeutic measures were taken as a result of covid-19. The COVID 19 Treatment includes of Paxlovid treatment started on 26Sep2022 to treatment stopped on 01Oct2022.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This patient also tested positive for COVID; This patient also tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1 (orange cap), single (Lot number: FK5127) and on 03Dec2021 as dose 2 (orange cap), single (Lot number: FK5127) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies", start date: 2019 (ongoing). The patient's family history included: "gestational diabetes" (unspecified if ongoing), notes: mom has gestational diabetes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Sep2022, outcome "recovered" (2022) and all described as "This patient also tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The report was not related to a study or program. Last known weight was taken in Jul2021. This event was not ongoing, but caller did not see any follow-up or information about when or how this event resolved. She thought this was tested for at school. The patient received third dose (lot: FL2757, expiry: 30Sep2022). Patient has not had any relative treatment or medical intervention to caller's awareness. Additional vaccines administered on same date of the Pfizer suspect, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. AE(s) following prior vaccinations: None that she was aware of.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201212817 similar report from same reporter;
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: The next day I had nose bleeds for more than 8 hours, it was random nose bleeds.  My son end up having to leave school because it was happening at anytime without a warning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerant" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy; "mild egg allergies" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy; "caffeine allergy" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization. The following information was reported: EPISTAXIS (medically significant) with onset 06Oct2022 at 06:00, outcome "recovered" (Oct2022), described as "The next day I had nose bleeds for more than 8 hours, it was random nose bleeds.  My son end up having to leave school because it was happening at anytime without a warning". Therapeutic measures were not taken as a result of epistaxis.  Additional information: Patient had no covid prior to vaccination and not tested covid post vaccination. Other medical history reported as not applicable.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: injection pain left arm; followed by neck pain; followed by cold symptoms like stuffiness; followed by cold symptoms like stuffiness; Cough; Fatigue; Low grade fever; mild headache; occasional chills; loss of appetite; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (COMIRNATY), on 28Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "mild HTN" (unspecified if ongoing), notes: Other medical history: mild HTN,; "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "vitiligo" (unspecified if ongoing), notes: Other medical history: vitiligo. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4), for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Sep2022 at 12:00, outcome "unknown", described as "Wrong vaccine administered"; COUGH (non-serious) with onset 02Oct2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Oct2022, outcome "recovering"; PYREXIA (non-serious) with onset 02Oct2022, outcome "recovering", described as "Low grade fever"; NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022, outcome "recovering" and all described as "followed by cold symptoms like stuffiness"; NECK PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "followed by neck pain"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "injection pain left arm"; DECREASED APPETITE (non-serious) with onset 02Oct2022, outcome "recovering", described as "loss of appetite"; HEADACHE (non-serious) with onset 02Oct2022, outcome "recovering", described as "mild headache"; CHILLS (non-serious) with onset 02Oct2022, outcome "recovering", described as "occasional chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, neck pain, nasopharyngitis, nasal congestion, cough, fatigue, pyrexia, headache, chills, decreased appetite.  Additional information: Patient received treatment Tylenol and patient did not had any Covid prior vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Neck pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: injection pain left arm; followed by neck pain; followed by cold symptoms like stuffiness; followed by cold symptoms like stuffiness; Cough; Fatigue; Low grade fever; mild headache; occasional chills; loss of appetite; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (COMIRNATY), on 28Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "mild HTN" (unspecified if ongoing), notes: Other medical history: mild HTN,; "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "vitiligo" (unspecified if ongoing), notes: Other medical history: vitiligo. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4), for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Sep2022 at 12:00, outcome "unknown", described as "Wrong vaccine administered"; COUGH (non-serious) with onset 02Oct2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Oct2022, outcome "recovering"; PYREXIA (non-serious) with onset 02Oct2022, outcome "recovering", described as "Low grade fever"; NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022, outcome "recovering" and all described as "followed by cold symptoms like stuffiness"; NECK PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "followed by neck pain"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "injection pain left arm"; DECREASED APPETITE (non-serious) with onset 02Oct2022, outcome "recovering", described as "loss of appetite"; HEADACHE (non-serious) with onset 02Oct2022, outcome "recovering", described as "mild headache"; CHILLS (non-serious) with onset 02Oct2022, outcome "recovering", described as "occasional chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, neck pain, nasopharyngitis, nasal congestion, cough, fatigue, pyrexia, headache, chills, decreased appetite.  Additional information: Patient received treatment Tylenol and patient did not had any Covid prior vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong product administered
Clinical narrative: injection pain left arm; followed by neck pain; followed by cold symptoms like stuffiness; followed by cold symptoms like stuffiness; Cough; Fatigue; Low grade fever; mild headache; occasional chills; loss of appetite; Wrong vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (COMIRNATY), on 28Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "mild HTN" (unspecified if ongoing), notes: Other medical history: mild HTN,; "hypothyroid" (unspecified if ongoing), notes: Other medical history: hypothyroid; "vitiligo" (unspecified if ongoing), notes: Other medical history: vitiligo. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3), for COVID-19 Immunization; Covid-19 vaccine (Dose: 4), for COVID-19 Immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Sep2022 at 12:00, outcome "unknown", described as "Wrong vaccine administered"; COUGH (non-serious) with onset 02Oct2022, outcome "recovering"; FATIGUE (non-serious) with onset 02Oct2022, outcome "recovering"; PYREXIA (non-serious) with onset 02Oct2022, outcome "recovering", described as "Low grade fever"; NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 02Oct2022, outcome "recovering" and all described as "followed by cold symptoms like stuffiness"; NECK PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "followed by neck pain"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2022, outcome "recovering", described as "injection pain left arm"; DECREASED APPETITE (non-serious) with onset 02Oct2022, outcome "recovering", described as "loss of appetite"; HEADACHE (non-serious) with onset 02Oct2022, outcome "recovering", described as "mild headache"; CHILLS (non-serious) with onset 02Oct2022, outcome "recovering", described as "occasional chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, neck pain, nasopharyngitis, nasal congestion, cough, fatigue, pyrexia, headache, chills, decreased appetite.  Additional information: Patient received treatment Tylenol and patient did not had any Covid prior vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Angiotensin converting enzyme, Biopsy, C-reactive protein, Computerised tomogram thorax, Endobronchial ultrasound transbronchial needle aspiration
Clinical narrative: MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "fatigue", "lethargy", "fever". The following information was reported: SARCOIDOSIS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE". The event "multisystem sarcoidosis associated with the covid-19 mrna vaccine" required physician office visit. Therapeutic measures were taken as a result of sarcoidosis.  Clinical course: she received her booster dose (~6 months after the second dose) and 2 weeks later, she noticed a right posterior calf mass that was firm and non-tender on exam. Rest of the exam was unremarkable. Orthopedic surgery was involved, and an excision biopsy was done. Pathology demonstrated non-necrotizing granulomatous inflammation. Her blood counts and metabolic panel were normal. Other labs showed elevated C-reactive protein of 19 mg/L (normal < 5 mg/L), angiotensin-converting enzyme level of 93 U/L (normal is 9-67) and Vitamin D level of 8.4 ng/mL (normal is 20-50 ng/mL). She was referred to pulmonary clinic for further evaluation. Pulmonary function test showed mild restrictive physiology. CT chest revealed enlarged mediastinal and hilar lymph nodes and lung parenchymal involvement. EBUS guided TBNA was performed and showed granulomatous inflammation.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event Sarcoidosis and the suspect drug  BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201213046 Same article/ drug/ patient and different event for different dose;US-PFIZER INC-PV202200078685 Same article/ drug/ patient and different event for different dose;
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Investigation, Metabolic function test, Pathology test, Pulmonary function test
Clinical narrative: MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "fatigue", "lethargy", "fever". The following information was reported: SARCOIDOSIS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE". The event "multisystem sarcoidosis associated with the covid-19 mrna vaccine" required physician office visit. Therapeutic measures were taken as a result of sarcoidosis.  Clinical course: she received her booster dose (~6 months after the second dose) and 2 weeks later, she noticed a right posterior calf mass that was firm and non-tender on exam. Rest of the exam was unremarkable. Orthopedic surgery was involved, and an excision biopsy was done. Pathology demonstrated non-necrotizing granulomatous inflammation. Her blood counts and metabolic panel were normal. Other labs showed elevated C-reactive protein of 19 mg/L (normal < 5 mg/L), angiotensin-converting enzyme level of 93 U/L (normal is 9-67) and Vitamin D level of 8.4 ng/mL (normal is 20-50 ng/mL). She was referred to pulmonary clinic for further evaluation. Pulmonary function test showed mild restrictive physiology. CT chest revealed enlarged mediastinal and hilar lymph nodes and lung parenchymal involvement. EBUS guided TBNA was performed and showed granulomatous inflammation.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event Sarcoidosis and the suspect drug  BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201213046 Same article/ drug/ patient and different event for different dose;US-PFIZER INC-PV202200078685 Same article/ drug/ patient and different event for different dose;
Sex: F
Vaccine: COVID19
Symptoms: Sarcoidosis, Vitamin D
Clinical narrative: MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation, reaction(s): "low grade fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "fatigue", "lethargy", "fever". The following information was reported: SARCOIDOSIS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "MULTISYSTEM SARCOIDOSIS ASSOCIATED WITH THE COVID-19 MRNA VACCINE". The event "multisystem sarcoidosis associated with the covid-19 mrna vaccine" required physician office visit. Therapeutic measures were taken as a result of sarcoidosis.  Clinical course: she received her booster dose (~6 months after the second dose) and 2 weeks later, she noticed a right posterior calf mass that was firm and non-tender on exam. Rest of the exam was unremarkable. Orthopedic surgery was involved, and an excision biopsy was done. Pathology demonstrated non-necrotizing granulomatous inflammation. Her blood counts and metabolic panel were normal. Other labs showed elevated C-reactive protein of 19 mg/L (normal < 5 mg/L), angiotensin-converting enzyme level of 93 U/L (normal is 9-67) and Vitamin D level of 8.4 ng/mL (normal is 20-50 ng/mL). She was referred to pulmonary clinic for further evaluation. Pulmonary function test showed mild restrictive physiology. CT chest revealed enlarged mediastinal and hilar lymph nodes and lung parenchymal involvement. EBUS guided TBNA was performed and showed granulomatous inflammation.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event Sarcoidosis and the suspect drug  BNT162b2  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201213046 Same article/ drug/ patient and different event for different dose;US-PFIZER INC-PV202200078685 Same article/ drug/ patient and different event for different dose;
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Dizziness, Dyspnoea
Clinical narrative: Headache; chills; body aches; nausea; dizziness; I don't feel good; tiredness; cough; chest heaviness; SOB; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 10:30 as dose 4 (booster), single (Lot number: Gh9693) at the age of 45 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Environmental" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Ff2587), administration date: 30Sep2021, when the patient was 44-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; MALAISE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "I don't feel good"; DYSPNOEA (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "SOB"; PAIN (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "body aches"; CHEST DISCOMFORT (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "chest heaviness"; CHILLS (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; COUGH (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; DIZZINESS (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; NAUSEA (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered"; FATIGUE (non-serious) with onset 06Oct2022 at 11:00, outcome "not recovered", described as "tiredness". Therapeutic measures were not taken as a result of headache, chills, pain, nausea, dizziness, malaise, fatigue, cough, chest discomfort, dyspnoea.  Additional information: No other vaccine in four weeks. If covid prior vaccination: Yes. If covid tested post vaccination: No.  Follow-up attempts are completed. No further information is expected.