chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 09:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nutopenia" (unspecified if ongoing); "Connective tissue disorder" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Gluten, reaction(s): "Known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: There was no other medication in 2weeks. Anti-viral product details: COVID 19 Treatment included Paxlovid treatment start date: 17Jul2022 and treatment stop date: 21Jul2022.known allergies were Gluten, Sulfa, Codeine, Shellfish and other medical history included Neutropenia, Connective tissue disorder, hypothyroidism. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (COVID-19 VACCINE MODERNA), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications received within 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19 included Anti-viral medication from 15Jul2022 to 19Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose 4 (booster), single (Lot number: FJ1614), in left arm and on 14Feb2022 as dose 5 (booster), single (Lot number: FM0698) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 at 16:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary Amyloidosis" (unspecified if ongoing); "Sjogren's syndrome" (unspecified if ongoing); "interstitial lung disease" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: EVUSHELD, on 19Apr2022; PREDNISONE, start date: Apr2022; ADVIL [IBUPROFEN], start date: Jan2022. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin"; Metoprolol, reaction(s): "Known allergies: metoprolol"; Molnuparavir, reaction(s): "Known allergies: molnuparavir"; Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Omeprazole, start date: Apr2011; Vyvanse, start date: Jan2018; Effexor, start date: Sep2016; Fluticasone, start date: May2017; Cevemeline, start date: May2010; Vitamin d, start date: Jan2016; Advil, start date: Jan2022; Prednisone, start date: Apr2022. The following information was reported: 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: (unspecified date) Positive, notes: COVID 19 Treatment; (Jul2022) Positive, notes: still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 27Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "recovering" and all described as "he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive. Clinical course: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) none. Family Medical History Relevant to AE(s): No. AE not resulted in Emergency Room and Physician Office visit. Patient reported that he got the original first 2 shots of COVID vaccine and got the booster shot and after a month was tested positive for COVID. Patient was the process of getting another booster shot. Patient received his booster dose in December and tested positive for COVID this Tuesday. Patient had dropped some weight over the last few days. Patient reported his fever had broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He had improved from the first day but still felt a lot of weakness. He wanted to know if there was medical treatment recommendation on what to do to alleviate his covid-19 symptoms.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pyrexia, Weight
Clinical narrative: he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 27Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "recovering" and all described as "he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive. Clinical course: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) none. Family Medical History Relevant to AE(s): No. AE not resulted in Emergency Room and Physician Office visit. Patient reported that he got the original first 2 shots of COVID vaccine and got the booster shot and after a month was tested positive for COVID. Patient was the process of getting another booster shot. Patient received his booster dose in December and tested positive for COVID this Tuesday. Patient had dropped some weight over the last few days. Patient reported his fever had broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He had improved from the first day but still felt a lot of weakness. He wanted to know if there was medical treatment recommendation on what to do to alleviate his covid-19 symptoms.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8734), in left arm, on 27Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "recovering" and all described as "he received his first Pfizer booster on DEC2021 and tested positive for Covid-19 last Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive. Clinical course: Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination) none. Family Medical History Relevant to AE(s): No. AE not resulted in Emergency Room and Physician Office visit. Patient reported that he got the original first 2 shots of COVID vaccine and got the booster shot and after a month was tested positive for COVID. Patient was the process of getting another booster shot. Patient received his booster dose in December and tested positive for COVID this Tuesday. Patient had dropped some weight over the last few days. Patient reported his fever had broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He had improved from the first day but still felt a lot of weakness. He wanted to know if there was medical treatment recommendation on what to do to alleviate his covid-19 symptoms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 at 08:00 as dose 1, single (Lot number: EH9099), in left arm, on 08Jan2021 at 07:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Oct2021 at 14:00 as dose 3 (booster), single (Lot number: EL1284) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulitis" (unspecified if ongoing), notes: other medical history: Diverticulitis; "childhood asthma" (unspecified if ongoing), notes: other medical history: childhood asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: Positive Covid test on 5th day after finishing Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included treatment with Paxlovid from 18Jul2022 to 21Jul2022. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: M
Vaccine: COVID19
Symptoms: CD30 expression, CD4/CD8 ratio, Condition aggravated, Histology, Pityriasis lichenoides et varioliformis acuta
Clinical narrative: pityriasis lichenoides et varioliformis acuta in Trunk, extremities; Dose 2, Progressed(Multiple papules); This is a literature report.  A male patient in his 10's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunisation. The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 23 days after the suspect product(s) administration, outcome "recovering", described as "pityriasis lichenoides et varioliformis acuta in Trunk, extremities"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: negative; CD4/CD8 ratio: 1:3; Histology: T-cell-predominant lymphoid infiltrates, notes: consistent with pityriasis lichenoides et varioliformis acuta; SARS-CoV-2 test: unknown; T-cell receptor gene rearrangement test: positive. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta, condition aggravated. Clinical information: Patient was in his late teens. Patient had no clinical history. All patients received the Pfizer/ BioNTechCOVID-19 mRNA vaccine. Median time between the first vaccine dose and lesion development was 22 days (range, 4-42 days). Cutaneous eruptions were characterized by single (n = 2) or generalized (n = 4) papulonodules on the trunk and/or extremities. Histologic examination revealed T-cell- predominant lymphoid infiltrates consistent with pityriasis lichenoides et varioliformis acuta. Events were near complete remission. Patient received treatment with oral doxycycline, narrowband UVB light and topical corticosteroids.; Sender's Comments: Based on the currently available information the possibility of causal association between the events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, T-cell receptor gene rearrangement test
Clinical narrative: pityriasis lichenoides et varioliformis acuta in Trunk, extremities; Dose 2, Progressed(Multiple papules); This is a literature report.  A male patient in his 10's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunisation. The following information was reported: PITYRIASIS LICHENOIDES ET VARIOLIFORMIS ACUTA (medically significant), 23 days after the suspect product(s) administration, outcome "recovering", described as "pityriasis lichenoides et varioliformis acuta in Trunk, extremities"; CONDITION AGGRAVATED (medically significant), outcome "recovering", described as "Dose 2, Progressed(Multiple papules)". The patient underwent the following laboratory tests and procedures: CD30 expression: negative; CD4/CD8 ratio: 1:3; Histology: T-cell-predominant lymphoid infiltrates, notes: consistent with pityriasis lichenoides et varioliformis acuta; SARS-CoV-2 test: unknown; T-cell receptor gene rearrangement test: positive. Therapeutic measures were taken as a result of pityriasis lichenoides et varioliformis acuta, condition aggravated. Clinical information: Patient was in his late teens. Patient had no clinical history. All patients received the Pfizer/ BioNTechCOVID-19 mRNA vaccine. Median time between the first vaccine dose and lesion development was 22 days (range, 4-42 days). Cutaneous eruptions were characterized by single (n = 2) or generalized (n = 4) papulonodules on the trunk and/or extremities. Histologic examination revealed T-cell- predominant lymphoid infiltrates consistent with pityriasis lichenoides et varioliformis acuta. Events were near complete remission. Patient received treatment with oral doxycycline, narrowband UVB light and topical corticosteroids.; Sender's Comments: Based on the currently available information the possibility of causal association between the events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: F
Vaccine: COVID19
Symptoms: CD30 expression, CD4/CD8 ratio, General symptom, Histology, Pseudolymphoma
Clinical narrative: Mild systemic symptoms; cutaneous lymphoid hyperplasia; This is a literature report.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Surgical excision" (unspecified if ongoing), notes: Done for CLH. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PSEUDOLYMPHOMA (medically significant), 22 days after the suspect product(s) administration, outcome "recovered", described as "cutaneous lymphoid hyperplasia"; GENERAL SYMPTOM (non-serious), outcome "recovered", described as "Mild systemic symptoms". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive; CD4/CD8 ratio: 2:1; Histology: revealed T-cell-predominant lymphoid infiltrates, notes: revealed T-cell-predominant lymphoid infiltrates: consistent with pityriasis lichenoides et varioliformis acuta (n = 2), cutaneous T-cell lymphoid hyperplasia (CLH) (n = 2), and lymphomatoid papulosis type A (n = 2); T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, general symptom.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event pseudolymphoma and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: F
Vaccine: COVID19
Symptoms: T-cell receptor gene rearrangement test
Clinical narrative: Mild systemic symptoms; cutaneous lymphoid hyperplasia; This is a literature report.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Surgical excision" (unspecified if ongoing), notes: Done for CLH. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PSEUDOLYMPHOMA (medically significant), 22 days after the suspect product(s) administration, outcome "recovered", described as "cutaneous lymphoid hyperplasia"; GENERAL SYMPTOM (non-serious), outcome "recovered", described as "Mild systemic symptoms". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive; CD4/CD8 ratio: 2:1; Histology: revealed T-cell-predominant lymphoid infiltrates, notes: revealed T-cell-predominant lymphoid infiltrates: consistent with pityriasis lichenoides et varioliformis acuta (n = 2), cutaneous T-cell lymphoid hyperplasia (CLH) (n = 2), and lymphomatoid papulosis type A (n = 2); T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, general symptom.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event pseudolymphoma and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: M
Vaccine: COVID19
Symptoms: CD30 expression, CD4/CD8 ratio, Cutaneous lymphoma, Histology, T-cell receptor gene rearrangement test
Clinical narrative: cutaneous lymphoid hyperplasia; This is a literature report for the following literature source(s).  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Biopsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CUTANEOUS LYMPHOMA (medically significant), 28 days after the suspect product(s) administration, outcome "recovered", described as "cutaneous lymphoid hyperplasia". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive; CD4/CD8 ratio: 3:1; Histology: revealed T-cell-predominant lymphoid infiltrates, notes: consistent with pityriasis lichenoides etvarioliformis acuta (n = 2), cutaneous T-cell lymphoid hyperplasia (CLH) (n = 2), and lymphomatoid papulosis type A (n = 2); T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of cutaneous lymphoma.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cutaneous lymphoma with the suspect product 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 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) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, CD30 expression, CD4/CD8 ratio, Fatigue, Histology
Clinical narrative: cutaneous lymphoid hyperplasia; Fatigue; This is a literature report.  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,Single), for COVID-19 immunization. The following information was reported: PSEUDOLYMPHOMA (medically significant), outcome "recovered", described as "cutaneous lymphoid hyperplasia"; FATIGUE (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy: Unknown result; CD30 expression: Positive; CD4/CD8 ratio: 3:1, notes: Unknown unit; Histology: Performed; SARS-CoV-2 test: Unknown result; T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, fatigue.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: M
Vaccine: COVID19
Symptoms: Pseudolymphoma, SARS-CoV-2 test, T-cell receptor gene rearrangement test
Clinical narrative: cutaneous lymphoid hyperplasia; Fatigue; This is a literature report.  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1,Single), for COVID-19 immunization. The following information was reported: PSEUDOLYMPHOMA (medically significant), outcome "recovered", described as "cutaneous lymphoid hyperplasia"; FATIGUE (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy: Unknown result; CD30 expression: Positive; CD4/CD8 ratio: 3:1, notes: Unknown unit; Histology: Performed; SARS-CoV-2 test: Unknown result; T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of pseudolymphoma, fatigue.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: that received his Pfizer COIVD-19 vaccine first 2 doses  about a year go and now today is going to start taking Paxlovid for Covid; that received his Pfizer COIVD-19 vaccine first 2 doses  about a year go and now today is going to start taking Paxlovid for Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jul2022, outcome "unknown" and all described as "that received his Pfizer COIVD-19 vaccine first 2 doses about a year go and now today is going to start taking Paxlovid for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Transferring agent states that the caller is an unspecified HCP called about a 63 year old patient who got two doses of the Covid 19 Vaccine about a year ago and is going to start Paxlovid today. The caller is inquired about when the patient should get his booster dose of the vaccine, his third dose of the vaccine. Patient has not consumed Paxlovid medication yet. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Sinusitis
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4482130-00. An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162623) at unknown, citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1:, Route of Admin: Intramuscular, Sinus surgery), for COVID-19 vaccination, reaction(s): "Sinus surgery"; Bnt162b2 (Dose 1:, Route of Admin: Intramuscular, Sinus infection), for COVID-19 vaccination, reaction(s): "Sinus infection". The following information was reported: SINUSITIS (medically significant), outcome "recovered", described as "Sinus infection"; INFLUENZA (non-serious), outcome "recovered", described as "Flu symptoms". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flu symptoms" related to BNT162b2. Clinical Course: Causality for Humira (Adalimumab). The reporter's causality for the event(s) of Sinus infection and Flu symptoms was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of Sinus infection and Flu symptoms are related to Humira (Adalimumab). Regulatory Authority opinion is that the event of Sinus infection is not assessable. Sinus infection (Sinusitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge: N/A 2) Flu symptoms (Influenza) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Dechallenge: N/A Drug: Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown Daily Dose: 1) First dose (1 in 1 Once), 2) Second dose (1 in 1 Once) Route of admin: 1) Intra-muscular, 2) Intra-muscular Causality for Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) (Tozinameran), Unknown:  1) Sinus infection (Sinusitis) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A 2) Flu symptoms (Influenza) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information provided in the narrative, a possible contributory role of the suspect vaccine to reported event of sinusitis and influenza cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Cutaneous vasculitis, Palpable purpura, Rash
Clinical narrative: LCV/small vessel vasculitis; severe rash 3-4 days after 3rd Pfizer shot; he had palpable purpura including torso, all extremities; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "hx HTN" (unspecified if ongoing); "stroke" (unspecified if ongoing); "prostate CA" (unspecified if ongoing), notes: prostate CA. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, product: COVID 19, brand name unknown: COVID19 Vaccine), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, product: COVID 19, brand name unknown: COVID19 Vaccine), for COVID-19 Immunization. The following information was reported: CUTANEOUS VASCULITIS (medically significant) with onset 22Apr2022, outcome "recovering", described as "LCV/small vessel vasculitis"; PALPABLE PURPURA (non-serious) with onset 22Apr2022, outcome "recovering", described as "he had palpable purpura including torso, all extremities"; RASH (non-serious) with onset 22Apr2022, outcome "recovering", described as "severe rash 3-4 days after 3rd Pfizer shot". The events "lcv/small vessel vasculitis", "severe rash 3-4 days after 3rd pfizer shot" and "he had palpable purpura including torso, all extremities" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: LCV/small vessel vasculitis. Therapeutic measures were taken as a result of cutaneous vasculitis, rash, palpable purpura.  Additional information: Adverse event: patient developed severe rash 3-4 days after 3rd Pfizer shot. He had palpable purpura including torso, all extremities. Skin biopsy with dermatologist showed LCV/small vessel vasculitis  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Investigational Conclusion of PQC: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: 7517780 Product Description: Compound BNT 162 Covid-19 Vaccine Suspension For Intramuscular 2ml Multiple Dose Vial X 1 Lot-#: FF2590 Conclusion of Previously Completed Investigation: The complaint for lack of effect of the pfizer biontech covid-19 vaccine injectable lot FF2590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Complete d Inv: 6592171 Link (Previously Investigate d): 6582386  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 12:00 as dose 2, single (Lot number: FE3594) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine janssen (COVID-19 VACCINE JANSSEN), on 21Mar2021 at 17:00 as dose 1, single (Lot number: AD26), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hypertension (controlled)" (unspecified if ongoing), notes: other medical history: hypertension (controlled); "GERD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "migraine" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ADVAIR; AMLODIPINE; OMEPRAZOLE; CETRIZINE; VIENVA; ALBUTEROL [SALBUTAMOL]; ZALEPLON; LORAZEPAM; EMGALITY [GALCANEZUMAB GNLM], start date: 04May2022; NARATRIPTAN, start date: 15Apr2022. Past drug history included: Morphine, reaction(s): "known allergies: Morphine"; Codeine, reaction(s): "known allergies: codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive, notes: positive home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoproliferative disorder, T-cell receptor gene rearrangement test
Clinical narrative: CD30-positive lymphoproliferative disorder; This is a literature report.  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "primary cutaneous anaplastic large cell lymphoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHOPROLIFERATIVE DISORDER (medically significant), outcome "recovering", described as "CD30-positive lymphoproliferative disorder". The patient underwent the following laboratory tests and procedures: T-cell receptor gene rearrangement test: Positive. Reaction for dose 1: Tumor - onset of 2 days from dose 1. Patient had lesions on Axilla. Diagnosis: CD30-positive lymphoproliferative disorder. Patient had no therapy/treatment and was near complete remission. No reaction for dose 2.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Rhinorrhoea
Clinical narrative: Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced; Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (First Booster; unknown manufacturer), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "Side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose; unknown if might have experienced".  Additional Information:Concern, caller stated, "I want to know, is there side effect after taking the second Booster (Pfizer COVID-19 Vaccine) like Diarrhoea and runny nose (unknown if might have experienced)?"  When paraphrased the concern, caller stated, "Right."As caller abruptly hung up the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling jittery, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: insides started felling jittery; having a hard time breathing; was having some kind of oxygen detoxification; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (ongoing), notes: Since she had migraines for all those years, they kept a detailed journal and has it written down when this all started. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FEELING JITTERY (non-serious), outcome "unknown", described as "insides started felling jittery"; DYSPNOEA (non-serious), outcome "unknown", described as "having a hard time breathing"; OXYGEN SATURATION DECREASED (non-serious), outcome "unknown", described as "was having some kind of oxygen detoxification". The events "insides started felling jittery", "having a hard time breathing" and "was having some kind of oxygen detoxification" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, the patient had second shot about 6 months ago for Covid. One week later, her insides started felling jittery and was having a hard time breathing. Was really bad in the morning time. They had been going to the doctors and she was having some kind of oxygen detoxification and they were putting her in a chamber but that has not been helping. Patient also had migraines and had not had migraines a long time before taking that Covid shot. Since she had migraines for all those years, they kept a detailed journal and has it written down when this all started. Was a week after the last shot, she was having migraines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.