chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use" (unspecified if ongoing), notes: 2-4 drinks/ per week; "Migraines" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "arthralgias" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 42 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 57 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: negative; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 58 IU/l; Blood alkaline phosphatase: 147 IU/l; Blood bilirubin: 0.4 mg/dl; Body mass index: 27.4; ASMA: negative; Serum ferritin: 662 ng/ml.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event liver injury cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article;suspect;event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antibody test, Antimitochondrial antibody, Antinuclear antibody, Aspartate aminotransferase
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: 7 drinks/week; "Hypertension" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 82 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 904 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: positive; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 828 IU/l; Biopsy liver: Mixed lymphoplasmacellular infiltrates with mild, notes: to moderate interface hepatitis, focal bridging necrosis and focal multicinar necrosis. Consistent with AIH superimposed by DILI or DILI initiated AIH; Blood alkaline phosphatase: 85 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 2127; Blood immunoglobulin M: 66; Body mass index: 28.9; Imaging procedure: US normal; ASMA: positive; Liver function test: Incidental elevation; Serum ferritin: 604 ng/ml; Transient elastography: 3.5, notes: Unit: kPa; CAP 152, notes: kPa 3.5; Ultrasound liver: Normal.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Biopsy liver, Blood alkaline phosphatase, Blood bilirubin, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: 7 drinks/week; "Hypertension" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 82 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 904 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: positive; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 828 IU/l; Biopsy liver: Mixed lymphoplasmacellular infiltrates with mild, notes: to moderate interface hepatitis, focal bridging necrosis and focal multicinar necrosis. Consistent with AIH superimposed by DILI or DILI initiated AIH; Blood alkaline phosphatase: 85 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 2127; Blood immunoglobulin M: 66; Body mass index: 28.9; Imaging procedure: US normal; ASMA: positive; Liver function test: Incidental elevation; Serum ferritin: 604 ng/ml; Transient elastography: 3.5, notes: Unit: kPa; CAP 152, notes: kPa 3.5; Ultrasound liver: Normal.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Imaging procedure, Investigation, Liver function test, Liver injury
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: 7 drinks/week; "Hypertension" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 82 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 904 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: positive; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 828 IU/l; Biopsy liver: Mixed lymphoplasmacellular infiltrates with mild, notes: to moderate interface hepatitis, focal bridging necrosis and focal multicinar necrosis. Consistent with AIH superimposed by DILI or DILI initiated AIH; Blood alkaline phosphatase: 85 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 2127; Blood immunoglobulin M: 66; Body mass index: 28.9; Imaging procedure: US normal; ASMA: positive; Liver function test: Incidental elevation; Serum ferritin: 604 ng/ml; Transient elastography: 3.5, notes: Unit: kPa; CAP 152, notes: kPa 3.5; Ultrasound liver: Normal.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Transient elastography, Ultrasound liver
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: 7 drinks/week; "Hypertension" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Graves disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for COVID-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 82 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 904 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: positive; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 828 IU/l; Biopsy liver: Mixed lymphoplasmacellular infiltrates with mild, notes: to moderate interface hepatitis, focal bridging necrosis and focal multicinar necrosis. Consistent with AIH superimposed by DILI or DILI initiated AIH; Blood alkaline phosphatase: 85 IU/l; Blood bilirubin: 0.8 mg/dl; Blood immunoglobulin G: 2127; Blood immunoglobulin M: 66; Body mass index: 28.9; Imaging procedure: US normal; ASMA: positive; Liver function test: Incidental elevation; Serum ferritin: 604 ng/ml; Transient elastography: 3.5, notes: Unit: kPa; CAP 152, notes: kPa 3.5; Ultrasound liver: Normal.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Antibody test, Antimitochondrial antibody, Antineutrophil cytoplasmic antibody, Antinuclear antibody
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: less than 1 drink/ week; "HSV2" (unspecified if ongoing); "fever" (unspecified if ongoing); "chills" (unspecified if ongoing); "myalgias" (unspecified if ongoing); "lymphadenopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for covid-19 immunization. The following information was reported: LIVER INJURY (medically significant), 81 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Normal, notes: Return to baseline; Alanine aminotransferase: 596 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: unknown result; Antineutrophil cytoplasmic antibody: positive; Antinuclear antibody: unknown result; Aspartate aminotransferase: Normal, notes: Return to baseline; Aspartate aminotransferase: 454 IU/l; Biopsy liver: focal portal fibrosis. Perivenular, notes: necroinflamtion with hepatocyte dropout, mild lymphocytic inflammation and ceroid containing macrophages. mild predominantly centrilobular small-droplet steatosis. Consistent with acute drug/toxin induced liver injury; Blood alkaline phosphatase: 213 IU/l; Blood bilirubin: 1.7 mg/dl; Blood immunoglobulin G: Unknown result; Blood immunoglobulin M: Unknown result; Body mass index: 19.6; Hepatitis viral test: negative; Imaging procedure: mildly echogenic liver; anti-smooth muscle antibodies: unknown result; unknown result; Magnetic resonance cholangiopancreatography: Normal; Serum ferritin: 358 ng/ml; Transient elastography: 3.4, notes: Unit: kPa; CAP 155, notes: kPa 3.4; Ultrasound liver: mildly echogenic liver.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Biopsy liver, Blood alkaline phosphatase, Blood bilirubin, Blood immunoglobulin G
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: less than 1 drink/ week; "HSV2" (unspecified if ongoing); "fever" (unspecified if ongoing); "chills" (unspecified if ongoing); "myalgias" (unspecified if ongoing); "lymphadenopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for covid-19 immunization. The following information was reported: LIVER INJURY (medically significant), 81 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Normal, notes: Return to baseline; Alanine aminotransferase: 596 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: unknown result; Antineutrophil cytoplasmic antibody: positive; Antinuclear antibody: unknown result; Aspartate aminotransferase: Normal, notes: Return to baseline; Aspartate aminotransferase: 454 IU/l; Biopsy liver: focal portal fibrosis. Perivenular, notes: necroinflamtion with hepatocyte dropout, mild lymphocytic inflammation and ceroid containing macrophages. mild predominantly centrilobular small-droplet steatosis. Consistent with acute drug/toxin induced liver injury; Blood alkaline phosphatase: 213 IU/l; Blood bilirubin: 1.7 mg/dl; Blood immunoglobulin G: Unknown result; Blood immunoglobulin M: Unknown result; Body mass index: 19.6; Hepatitis viral test: negative; Imaging procedure: mildly echogenic liver; anti-smooth muscle antibodies: unknown result; unknown result; Magnetic resonance cholangiopancreatography: Normal; Serum ferritin: 358 ng/ml; Transient elastography: 3.4, notes: Unit: kPa; CAP 155, notes: kPa 3.4; Ultrasound liver: mildly echogenic liver.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Body mass index, Hepatitis viral test, Imaging procedure, Investigation
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: less than 1 drink/ week; "HSV2" (unspecified if ongoing); "fever" (unspecified if ongoing); "chills" (unspecified if ongoing); "myalgias" (unspecified if ongoing); "lymphadenopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for covid-19 immunization. The following information was reported: LIVER INJURY (medically significant), 81 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Normal, notes: Return to baseline; Alanine aminotransferase: 596 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: unknown result; Antineutrophil cytoplasmic antibody: positive; Antinuclear antibody: unknown result; Aspartate aminotransferase: Normal, notes: Return to baseline; Aspartate aminotransferase: 454 IU/l; Biopsy liver: focal portal fibrosis. Perivenular, notes: necroinflamtion with hepatocyte dropout, mild lymphocytic inflammation and ceroid containing macrophages. mild predominantly centrilobular small-droplet steatosis. Consistent with acute drug/toxin induced liver injury; Blood alkaline phosphatase: 213 IU/l; Blood bilirubin: 1.7 mg/dl; Blood immunoglobulin G: Unknown result; Blood immunoglobulin M: Unknown result; Body mass index: 19.6; Hepatitis viral test: negative; Imaging procedure: mildly echogenic liver; anti-smooth muscle antibodies: unknown result; unknown result; Magnetic resonance cholangiopancreatography: Normal; Serum ferritin: 358 ng/ml; Transient elastography: 3.4, notes: Unit: kPa; CAP 155, notes: kPa 3.4; Ultrasound liver: mildly echogenic liver.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Liver injury, Magnetic resonance cholangiopancreatography, Serum ferritin, Transient elastography, Ultrasound liver
Clinical narrative: COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: less than 1 drink/ week; "HSV2" (unspecified if ongoing); "fever" (unspecified if ongoing); "chills" (unspecified if ongoing); "myalgias" (unspecified if ongoing); "lymphadenopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for covid-19 immunization. The following information was reported: LIVER INJURY (medically significant), 81 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Normal, notes: Return to baseline; Alanine aminotransferase: 596 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: unknown result; Antineutrophil cytoplasmic antibody: positive; Antinuclear antibody: unknown result; Aspartate aminotransferase: Normal, notes: Return to baseline; Aspartate aminotransferase: 454 IU/l; Biopsy liver: focal portal fibrosis. Perivenular, notes: necroinflamtion with hepatocyte dropout, mild lymphocytic inflammation and ceroid containing macrophages. mild predominantly centrilobular small-droplet steatosis. Consistent with acute drug/toxin induced liver injury; Blood alkaline phosphatase: 213 IU/l; Blood bilirubin: 1.7 mg/dl; Blood immunoglobulin G: Unknown result; Blood immunoglobulin M: Unknown result; Body mass index: 19.6; Hepatitis viral test: negative; Imaging procedure: mildly echogenic liver; anti-smooth muscle antibodies: unknown result; unknown result; Magnetic resonance cholangiopancreatography: Normal; Serum ferritin: 358 ng/ml; Transient elastography: 3.4, notes: Unit: kPa; CAP 155, notes: kPa 3.4; Ultrasound liver: mildly echogenic liver.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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-PV202300089305 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: headache; migraine; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown".  Additional information: The patient noticed, after second dose of the COVID vaccine, headache within the hour and it induced a migraine within the same day. That migraine lasted a few days. Also noticed an increase in frequency and duration with migraines and migraine symptoms since after receiving the second dose, and all boosters of the COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Infertility male
Clinical narrative: Fertility problems; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY MALE (non-serious), outcome "unknown", described as "Fertility problems".  Additional information: Pfizer Employee stated, "I just was at the grocery store and there was somebody talking about how they have heard of somebody getting from the COVID vaccine fertility problems, it was a lady that was talking. I do not have any questions, I was just calling in as an adverse event. The person had the COVID vaccine, Pfizer COVID Vaccine, I don't know how long it had been but then now they are having fertility problems and something she was talking about. I don't even know the person, I was just at the grocery store. I just know it was a man. Well I work for Pfizer. I have no idea who the person even was I just overheard it, she was really loud."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blister infected, Blood pressure measurement, Blood test, Condition aggravated
Clinical narrative: getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller; getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07May2023 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD; "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2; Unknown Manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 3; Unknown Manufacturer), for covid-19 immunization. The following information was reported: BLISTER INFECTED (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "getting blisters on his hands and fingers that he never get that before; they are getting bigger instead of smaller". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blister infected, condition aggravated.  Additional information: Getting blisters on his hands and fingers that he never gets that before; they are getting bigger instead of smaller was reported as worsened. Consumer stated, "The first two were the COVID-19 Shot but I do not know if this is another booster or not because they want me to come back for another one. That's what I mean, the information is not right. How many shots you are supposed to take for this". Consumer stated, "I am just telling you I am taking the medications. I am not going to sit here and go through all my medication list. "I did blood work 2 weeks ago. All I have is blood drawn."  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single at the age of 37 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HCM" (unspecified if ongoing). 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 "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2023) Negative, notes: tested negative on 08May2023; (12May2023) Positive, notes: tested positive for COVID 12May2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After taking the full round of Paxlovid, symptoms ended and tested negative on 08May2023. Symptoms returned 10May2023, and tested positive for COVID 12May2023. Symptoms were continuing as of 18May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Former smoker" (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 "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid rebound, return of symptoms & tested positive for Covid on 18May2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Viral related asthma" (unspecified if ongoing); "chronic migraine" (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 "product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Symptoms were nearly absent, only had some fatigue on day 10 with no sinus congestion. Woke up on Day 11 to severe Nasal congestion, sore throat, increased fatigue. 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 the given information , the possible contributory role of the suspect for the events drug ineffective and covid-19 cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), 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.  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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine to drug ineffective (LOE) and covid 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300195890 Same patient, different drug/AE;US-PFIZER INC-202300196951 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Nausea, Pyrexia, Radiculitis brachial
Clinical narrative: left brachial neuritis; nausea; fever; This is a literature report.  A 29-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Mrna sars-cov2 (Dose 1 Single, left arm), for covid-19 immunization, reaction(s): "mild pain at the injection site". The following information was reported: RADICULITIS BRACHIAL (medically significant), outcome "recovering", described as "left brachial neuritis"; NAUSEA (medically significant), outcome "unknown"; PYREXIA (medically significant), outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: Electromyogram: left brachial neuritis. Therapeutic measures were taken as a result of radiculitis brachial.  Clinical course: 29 year-old male received his firstmRNA SARS-CoV-2 n his left arm. He had isolated persistent mild pain at the injection site. This prompted him to receive his second vaccine in his right arm three weeks later. Within a few hours of the injection, he had fever, nausea, and severe pain near his left tricep and olecranon process. The severe pain improved somewhat after treatment with opiates. In the next two weeks, he developed left arm weakness, numbness in his left fourth and fifth digits, with eventual muscle wasting of his left trapezius. The weakness was profound and prevented him from performing activities of daily living. An EMG confirmed the diagnosis of left brachial neuritis. He was treated with oral steroids, physical therapy, and improved within several months with residual mild paresthesias. He received the influenza vaccine approximately six months later in his right arm. The exact symptoms returned in his left arm, though milder, and self-resolved after a week.; Sender's Comments: Based on the available information in the case, an association between the reported events RADICULITIS BRACHIAL ,NAUSEA, PYREXIA  and The suspected drug cannot be ruled out.  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-PV202300089693 Same article/suspect/patient and different event;
Age: 69.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 22Dec2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300197291 same reporter/patient, different product/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Found out on 18May2023 that the participant tested positive for COVID that day; Found out on 18May2023 that the participant tested positive for COVID that day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65-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 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2023, outcome "recovering" and all described as "Found out on 18May2023 that the participant tested positive for COVID that day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received vaccine at clinic. Reporter stated that the patient received 2 dose series manufactured by Pfizer around Jan2021 and believed that patient had also received booster doses, reporter was not sure how many or which manufacturer. Reporter found out on 18May2023 that the participant tested positive for COVID that day, after feeling under the weather. Reporter did not know the exact symptoms or onset of symptoms. The participant was prescribed Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic dissection
Clinical narrative: Heart aortic dissection; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2022 as dose 4 (booster), single (Lot number: FJ6369, Expiration Date: May2022) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Aug2020, for COVID-19 immunisation, reaction(s): "terrible headache", "severe diarrhea"; BNT162b2 (DOSE 2, SINGLE), administration date: 15Sep2020, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Batch/Lot number: FC3184; Expiration: Oct2021), administration date: 02Sep2021, for COVID-19 immunisation. The following information was reported: AORTIC DISSECTION (hospitalization, medically significant) with onset 07Sep2022, outcome "unknown", described as "Heart aortic dissection". Therapeutic measures were taken as a result of aortic dissection. Clinical course: Valve replacement of her heart aortic dissection and stent was also placed during this serious operation on her heart. She was a participant in a trial of developing the Pfizer covid vaccine. Patient had Other Conditions and no Investigations were performed. She did not know if she received a different dose since she was a senior.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190182 Same patient/vaccine, different dose/events (dose 5);US-PFIZER INC-202300190194 Same patient/vaccine, different dose/events (dose 1);
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 4 (booster), single (Lot number: 9H9694) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: treated with statin. Concomitant medication(s) included: ROSUVASTATIN, start date: 01Mar2022, stop date: 11May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive the COVID-19; I tested positive the COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 28-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I tested positive the COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Atrial fibrillation, Deep vein thrombosis, Drug ineffective, Pericarditis
Clinical narrative: Covid; Covid; Pericarditis; Pulmonary Embolisms in both lungs; DVT in right calf; pneumonia; A Fib; I have asthma which has gotten extremely worse after Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have asthma" (unspecified if ongoing), notes: I have asthma which has gotten extremely worse after Covid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; PERICARDITIS (medically significant), outcome "unknown"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "Pulmonary Embolisms in both lungs"; DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "DVT in right calf"; PNEUMONIA (medically significant), outcome "unknown"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A Fib"; ASTHMA (non-serious), outcome "unknown", described as "I have asthma which has gotten extremely worse after Covid". The patient underwent the following laboratory tests and procedures: Scan myocardial perfusion: failed.  Clinical course: Patient had complications due to Covid. Pericarditis, Pulmonary Embolisms in both lungs, DVT in right calf, and rare pneumonia that Covid causes. I had all shots. My health was very poor. I also went from NSR into A Fib. I have asthma which has gotten extremely worse after Covid. I failed a Nuclear Stress test. Medical Information  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.