chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cytomegalovirus infection, Cytomegalovirus test, Lymphocyte count, Polymerase chain reaction, SARS-CoV-2 antibody test
Clinical narrative: CMV infection within 45 d of COVID-19 mRNA vaccination; This is a literature report for the following literature source(s).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bilateral lung transplant" (unspecified if ongoing), notes: Time since transplant 22 month; "Bronchiectasis" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "idiopathic pulmonary fibrosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for immunosuppression, notes: 500 mg twice day; Mycophenolate for immunosuppression, notes: 500 mg twice day; Prednisone for immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (FIRST DOSE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (hospitalization, medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "CMV infection within 45 d of COVID-19 mRNA vaccination". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1, notes: Admission; Polymerase chain reaction: 15900 IU/ml, notes: highest serum; Polymerase chain reaction (normal high range 200): 42, notes: greater than; SARS-CoV-2 antibody test: negative; Transplant evaluation: 3, notes: months before first CMV  vaccine; plus minus, notes: (±); White blood cell count: 4, notes: admission. Therapeutic measures were taken as a result of cytomegalovirus infection.  Follow-up (29Jun2022): This is a literature report for the following literature source entitled. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  updated information include : reporter information, RMH, Lab data, product coding, treatment received.; Sender's Comments: As there is limited information in the case provided, the causal association between reported the event  and the suspect drug 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) : US-PFIZER INC-202200916514 original case PV202200004629;US-PFIZER INC-202200916515 original case PV202200004629;
Sex: M
Vaccine: COVID19
Symptoms: Transplant evaluation, White blood cell count
Clinical narrative: CMV infection within 45 d of COVID-19 mRNA vaccination; This is a literature report for the following literature source(s).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bilateral lung transplant" (unspecified if ongoing), notes: Time since transplant 22 month; "Bronchiectasis" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "idiopathic pulmonary fibrosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for immunosuppression, notes: 500 mg twice day; Mycophenolate for immunosuppression, notes: 500 mg twice day; Prednisone for immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (FIRST DOSE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (hospitalization, medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "CMV infection within 45 d of COVID-19 mRNA vaccination". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1, notes: Admission; Polymerase chain reaction: 15900 IU/ml, notes: highest serum; Polymerase chain reaction (normal high range 200): 42, notes: greater than; SARS-CoV-2 antibody test: negative; Transplant evaluation: 3, notes: months before first CMV  vaccine; plus minus, notes: (±); White blood cell count: 4, notes: admission. Therapeutic measures were taken as a result of cytomegalovirus infection.  Follow-up (29Jun2022): This is a literature report for the following literature source entitled. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  updated information include : reporter information, RMH, Lab data, product coding, treatment received.; Sender's Comments: As there is limited information in the case provided, the causal association between reported the event  and the suspect drug 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) : US-PFIZER INC-202200916514 original case PV202200004629;US-PFIZER INC-202200916515 original case PV202200004629;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine; This is a literature report.  A 67 year old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "overlap connective tissue disease" (ongoing), notes: on mycophenolate mofetil. Concomitant medication(s) included: MYCOPHENOLATE MOFETIL taken for connective tissue disorder. The following information was reported: DRUG INEFFECTIVE (caused and prolonged hospitalization, medically significant), PULMONARY EMBOLISM (caused and prolonged hospitalization, medically significant), COVID-19 (caused and prolonged hospitalization, medically significant), outcome "unknown" and all described as "severe COVID-19 disease complicated by pulmonary embolism despite receiving three doses of the BNT162b2 mRNA vaccine". The event "severe covid-19 disease complicated by pulmonary embolism despite receiving three doses of the bnt162b2 mrna vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: Positive. Therapeutic measures were taken as a result of vaccination failure, pulmonary embolism, covid-19.  Follow-up (30Jun2022): This is a literature report. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  Updated information included: Reporter and literature information, lab test, product details and event details updated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Pulmonary embolism, cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: patient presented with an episode of anaphylaxis ten minutes after receiving the vaccine; This is a literature report.  A female patient received BNT162b2 (BNT162B2), 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 patient had no history of allergies.  The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "patient presented with an episode of anaphylaxis ten minutes after receiving the vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile and close temporal relationship.,Linked Report(s) : US-PFIZER INC-202200014230 Same article/drug/event/ different patient;
Sex: M
Vaccine: COVID19
Symptoms: Furuncle, Oral disorder
Clinical narrative: have boils on my face; at the area injected at oral commissures looks like fat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-062922-16304.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66  for covid-19 immunisation; hyaluronic acid (RESTYLANE), in Jan2022 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISORDER (non-serious) with onset 2022, outcome "unknown", described as "at the area injected at oral commissures looks like fat"; FURUNCLE (non-serious) with onset 2022, outcome "unknown", described as "have boils on my face". Therapeutic measures were not taken as a result of oral disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Case Detail Report: Galderma Reference Number: GL-062922-16304 Patient Identifiers: As (DOB withheld) 67-year-old male HCP Contact Information: (Name withheld) (patient reporter) (email and phone number withheld)  Reported Adverse Event Per Consumer (speaks only Spanish) Visited the Dermatologist and she injected Restylane this was done the end of Jan2022. Every place she injected the product I have boils on my face. Injector: (Name, address and phone number withheld). Event date: Either the end of Jan2022 or beginning of Feb2022  Event: Boils in face where injected - and at the area injected at oral commissures looks like fat. Event began immediately after injection of Restylane Contour to my cheeks and Restylane Refyne to my nasolabial folds and oral commissures. I was very unhappy with results, so six days after she injected me, I went to the office and saw her. She took before and after pictures, but they were from far away-not close up.  Treatment instructions: She told me it was a normal process. She did not treat anything. She asked me if I wanted more filler injected instead. I sent her (doctor) at least four or five emails. She wrote back but gave very simple answers. Patient had Pfizer Covid-19 vaccines on 25Feb2021, 18Mar2021 and a booster on 01Oct2021. Patient uses no other medications.  Follow-up (01Jul2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Updated Information: Patient information (DOB, age added).  Additional Information: Query: Could you please help provided correct DOB since incorrect format was provided. Response: Our apologies, the correct DOB is (date withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin, Blood albumin decreased, Blood cholesterol, Blood cholesterol increased, Blood pressure measurement
Clinical narrative: immobility; irreversible kidney damage; Mild foor eyelid swelling; low albumin; +360 cholesterol; Foamy urine; HBP; impaired cognition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing). Concomitant medication(s) included: ADDERALL oral taken for attention deficit hyperactivity disorder (ongoing).  The following information was reported: IMMOBILE (medically significant), outcome "unknown", described as "immobility"; RENAL INJURY (medically significant), outcome "unknown", described as "irreversible kidney damage"; SWELLING OF EYELID (non-serious), outcome "unknown", described as "Mild foor eyelid swelling"; BLOOD ALBUMIN DECREASED (non-serious), outcome "unknown", described as "low albumin"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "+360 cholesterol"; URINE ABNORMALITY (non-serious), outcome "unknown", described as "Foamy urine"; HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "impaired cognition". The patient underwent the following laboratory tests and procedures: Blood albumin: low; Blood cholesterol: high, notes: +360 cholesterol; Blood pressure measurement: High, notes: HBP; Blood test: low albumin, low vitamin D, High cholesterol; Oedema: +20 lbs, notes: swelling progress to +20 lbs of edema; Urine analysis: loss of protein; Vitamin D: low. Therapeutic measures were taken as a result of immobile, renal injury, swelling of eyelid, blood albumin decreased, blood cholesterol increased, urine abnormality, hypertension, cognitive disorder.  Clinical course: Patient received second dose on 23May2021 at 11 AM on Left Arm (Batch/Lot Number: EW0185). Mild foor and eyelid swelling progress to more than 20 lbs of edema, low albumin, more than 360 cholesterol, foamy urine, HBP, immobility. Impaired cognition, irreversible kidney damage. Biopsy performed stated minimal change disease. She have never had any issues ever. Now on medication and dealing with this for life. The patient did not have any prior vaccinations within 4 weeks. Th patient's family history did not have any medical history relevant to the adverse events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cognitive disorder, Hypertension, Immobile, Oedema
Clinical narrative: immobility; irreversible kidney damage; Mild foor eyelid swelling; low albumin; +360 cholesterol; Foamy urine; HBP; impaired cognition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing). Concomitant medication(s) included: ADDERALL oral taken for attention deficit hyperactivity disorder (ongoing).  The following information was reported: IMMOBILE (medically significant), outcome "unknown", described as "immobility"; RENAL INJURY (medically significant), outcome "unknown", described as "irreversible kidney damage"; SWELLING OF EYELID (non-serious), outcome "unknown", described as "Mild foor eyelid swelling"; BLOOD ALBUMIN DECREASED (non-serious), outcome "unknown", described as "low albumin"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "+360 cholesterol"; URINE ABNORMALITY (non-serious), outcome "unknown", described as "Foamy urine"; HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "impaired cognition". The patient underwent the following laboratory tests and procedures: Blood albumin: low; Blood cholesterol: high, notes: +360 cholesterol; Blood pressure measurement: High, notes: HBP; Blood test: low albumin, low vitamin D, High cholesterol; Oedema: +20 lbs, notes: swelling progress to +20 lbs of edema; Urine analysis: loss of protein; Vitamin D: low. Therapeutic measures were taken as a result of immobile, renal injury, swelling of eyelid, blood albumin decreased, blood cholesterol increased, urine abnormality, hypertension, cognitive disorder.  Clinical course: Patient received second dose on 23May2021 at 11 AM on Left Arm (Batch/Lot Number: EW0185). Mild foor and eyelid swelling progress to more than 20 lbs of edema, low albumin, more than 360 cholesterol, foamy urine, HBP, immobility. Impaired cognition, irreversible kidney damage. Biopsy performed stated minimal change disease. She have never had any issues ever. Now on medication and dealing with this for life. The patient did not have any prior vaccinations within 4 weeks. Th patient's family history did not have any medical history relevant to the adverse events.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Renal injury, Swelling of eyelid, Urine abnormality, Urine analysis, Vitamin D
Clinical narrative: immobility; irreversible kidney damage; Mild foor eyelid swelling; low albumin; +360 cholesterol; Foamy urine; HBP; impaired cognition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0167) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (ongoing). Concomitant medication(s) included: ADDERALL oral taken for attention deficit hyperactivity disorder (ongoing).  The following information was reported: IMMOBILE (medically significant), outcome "unknown", described as "immobility"; RENAL INJURY (medically significant), outcome "unknown", described as "irreversible kidney damage"; SWELLING OF EYELID (non-serious), outcome "unknown", described as "Mild foor eyelid swelling"; BLOOD ALBUMIN DECREASED (non-serious), outcome "unknown", described as "low albumin"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "+360 cholesterol"; URINE ABNORMALITY (non-serious), outcome "unknown", described as "Foamy urine"; HYPERTENSION (non-serious), outcome "unknown", described as "HBP"; COGNITIVE DISORDER (non-serious), outcome "unknown", described as "impaired cognition". The patient underwent the following laboratory tests and procedures: Blood albumin: low; Blood cholesterol: high, notes: +360 cholesterol; Blood pressure measurement: High, notes: HBP; Blood test: low albumin, low vitamin D, High cholesterol; Oedema: +20 lbs, notes: swelling progress to +20 lbs of edema; Urine analysis: loss of protein; Vitamin D: low. Therapeutic measures were taken as a result of immobile, renal injury, swelling of eyelid, blood albumin decreased, blood cholesterol increased, urine abnormality, hypertension, cognitive disorder.  Clinical course: Patient received second dose on 23May2021 at 11 AM on Left Arm (Batch/Lot Number: EW0185). Mild foor and eyelid swelling progress to more than 20 lbs of edema, low albumin, more than 360 cholesterol, foamy urine, HBP, immobility. Impaired cognition, irreversible kidney damage. Biopsy performed stated minimal change disease. She have never had any issues ever. Now on medication and dealing with this for life. The patient did not have any prior vaccinations within 4 weeks. Th patient's family history did not have any medical history relevant to the adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Chest discomfort, Feeling abnormal, Influenza like illness, Investigation
Clinical narrative: chest discomfort; palpitations; flu-like symptoms; general malaise and feeling lousy; lingering symptoms; it's waxing and waning but he's still really quite ill; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: (177478).  A 67-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fairly extensive cardiac history" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (First Booster Dose; unknown manufacturer), for Covid-19 Immunisation. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "not recovered"; PALPITATIONS (non-serious), outcome "not recovered"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "flu-like symptoms"; MALAISE (non-serious), outcome "not recovered", described as "general malaise and feeling lousy"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "lingering symptoms; it's waxing and waning but he's still really quite ill". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient had a second COVID booster and about a day or two after that began to experience some chest discomfort, palpitations and had a very extensive cardiac workup since then, which had all been negative. Then during that time had also developed fairly significant, just general malaise and feeling lousy, kind of flu like symptoms. Again, workup was all negative for infectious causes and the only real factor was that second COVID booster. He still had lingering symptoms; it was waxing and waning but he was still really quite ill. He would be seeing a new cardiologist in mid-late July.  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: Malaise, Palpitations
Clinical narrative: chest discomfort; palpitations; flu-like symptoms; general malaise and feeling lousy; lingering symptoms; it's waxing and waning but he's still really quite ill; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: (177478).  A 67-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fairly extensive cardiac history" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation; Covid-19 vaccine (First Booster Dose; unknown manufacturer), for Covid-19 Immunisation. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "not recovered"; PALPITATIONS (non-serious), outcome "not recovered"; INFLUENZA LIKE ILLNESS (non-serious), outcome "not recovered", described as "flu-like symptoms"; MALAISE (non-serious), outcome "not recovered", described as "general malaise and feeling lousy"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "lingering symptoms; it's waxing and waning but he's still really quite ill". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the patient had a second COVID booster and about a day or two after that began to experience some chest discomfort, palpitations and had a very extensive cardiac workup since then, which had all been negative. Then during that time had also developed fairly significant, just general malaise and feeling lousy, kind of flu like symptoms. Again, workup was all negative for infectious causes and the only real factor was that second COVID booster. He still had lingering symptoms; it was waxing and waning but he was still really quite ill. He would be seeing a new cardiologist in mid-late July.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID 19; tested positive for COVID 19/ sore throat, cough and tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 21-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Jul2022, outcome "unknown", described as "tested positive for COVID 19"; COVID-19 (medically significant) with onset 01Jul2022, outcome "unknown", described as "tested positive for COVID 19/ sore throat, cough and tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) positive.  Clinical course: This 21-year-old female received the Pfizer COVID 19 vaccine on 13Apr2021, 04May2021 and a booster on 30Dec2021. On 01Jul2022 she developed a sore throat, cough and tiredness. On 04Jul2022 she tested positive for COVID 19. Event took place after use of product.  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: Pruritus, Urticaria
Clinical narrative: hives; itch; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: URTICARIA (non-serious), outcome "unknown", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "itch".  Additional information: The patient experienced hives since the first dose. Hives occur with 1-8 and itch badly. The patient had repeated hives. The event took place after the use of product.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US150960 (RA).  A 28-year-old female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".  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: Ageusia, Anosmia
Clinical narrative: I completely lost my sense of taste and smell; I completely lost my sense of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) with unspecified age and gender received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0162) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA , AGEUSIA  all with onset Apr2021, outcome "not recovered" and all described as "I completely lost my sense of taste and smell".  Additional Information: Case Category: Product Specific Inquiry Case Subcategory: Adverse Event/Product Complaint  Description of Event Outcome I have Pfizer COVID-19 vaccine, EW0162, on 13Apr2021. Approximately four days after I completely lost my sense of taste and smell. It continued and by the time for the second shot, EE0169, 04May2021 I still received my dose. My sense of smell and taste has never returned in any normal or consistent capacity. I did receive one booster, FJ5682, 06Feb2022. I can't always taste salt, sometimes I can smell the food but can't taste what I smell. Coffee is a toss up. Can you help?  Event Awareness Date: 03Jul2022  No follow-ups attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200926528 same reporter/patient, different drug, similar event;US-PFIZER INC-202200926529 same reporter/patient, different drug, similar event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: suffering from difficult covid symptoms; suffering from difficult covid symptoms; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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 "suffering from difficult covid symptoms". Clinical course: The patient double Pfizer vaccinated and boosted was in his 3 month of suffering from difficult COVID symptoms. Since withheld recently opened its borders there were no long COVID clinics and inadequate medical expertise. He'd just to speak with someone knowledgeable and perhaps got some advice for managing the difficult days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood, Feeling abnormal
Clinical narrative: first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,; first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN: LRN4535447, 7793-2123331565.  A 39-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EUPHORIC MOOD (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric,". Additional information:  it was reported that patient experienced: No immune response to COVID vaccine, first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute; second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute; first COVID vaccine was on 15Mar2021, second COVID vaccine on 31MAR2021; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN: LRN4535447, 7793-2123331565.  A 39-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: Patient's concurrent condition included: Multiple Sclerosis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 15Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "first COVID vaccine was on 15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric"; The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Mar2021, outcome "unknown", described as "first COVID vaccine was on 15Mar2021, second COVID vaccine on 31MAR2021"; HEART RATE INCREASED (medically significant), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "second COVID vaccine was on 31Mar2021 and it "kicked my ass" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute". The patient underwent the following laboratory tests and procedures: Heart rate: 140, notes: his heart rate was 140 beats per minute. Clinical course: On 15Mar2021, patient started therapy with Pfizer COVID-19 VACCINE for unknown indication On unknown date , it was reported that patient experienced: No immune response to COVID vaccine, first COVID vaccine was on15Mar2021 and it make him feel high like when he used to do LSD which was further described as euphoric, second COVID vaccine was on 31Mar2021 and it "kicked my butt" which was further clarified as the patient was laying in bed and his heart rate was 140 beats per minute.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness
Clinical narrative: I just got COVID/The Symptoms are horrible; I just got COVID/The Symptoms are horrible; I came home sicker than I went in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just got COVID/The Symptoms are horrible"; ILLNESS (non-serious), outcome "unknown", described as "I came home sicker than I went in". The events "i just got covid/the symptoms are horrible" and "i came home sicker than i went in" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19, illness with Molnupiravir 200. Patient is fully vax and boosted with Pfizer. Patient just got covid and it was right away. Patient went to the ER and ended up catching it Patient came home sicker than thy went in. Patient was given Molnupiravir 200 to take 4 pills in am 4 pills in pm today is the last day. Patient is asking if a new booster is getting ready. Patient do not want to get covid again the symptoms are horrible.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Urinary tract infection
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-163-4453553-00. A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for rheumatoid arthritis. 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 "recovered" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious), outcome "recovered". The action taken for adalimumab was unknown. The reporter considered "Covid-19" and "urinary tract infection" related to BNT162b2. Causality for Humira (Adalimumab) was given as the reporter's causality for the event(s) of Urinary tract infection and COVID with Humira (Adalimumab) was a reasonable possibility. The reporter's assessment of the causal relationship of "Covid-19" 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 "Covid-19" and "urinary tract infection" related to BNT162b2. Clinical course: Patient did not have any known allergies. Patient did not have relevant medical history. Patient did not take concomitant drugs. On unknown dates, the patient experienced urinary tract infection and COVID. On unknown dates, urinary tract infection and COVID resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Daily dose was given as Citrate free for Humira (Solution for injection in pre-filled pen) (Adalimumab). 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 available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary fibrosis
Clinical narrative: Pulmonary fibrosis; 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-163-4450845-00.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Lot number: 1159488), oral for rheumatoid arthritis. 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. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "recovering". The action taken for upadacitinib was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of pulmonary fibrosis with Rinvoq (Upadacitinb) was no reasonable possibility.  The reporter causality for event "pulmonary fibrosis" is possible to BNT162b2.  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 available, the causal relationship between the reported event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID".  Clinical course: Patient was fully vaccinated with your COVID vaccine. Patient was fortunate to be a very good health. Unfortunately, Patient still contracted COVID and had flu-like symptoms for a week and patient still have a dry, hacking cough over two weeks later. Patient was told had the Omicron variant. Patient was told by patient county's epidemiologist that there was significant spread this summer in where patient reside.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: I came down with Covid; I came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and 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 "I came down with Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Patient's family follows the guidelines set, have had their vaccines thru Pfizer and boosted. Now just recently, patient came down with covid, it has been so very mild.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 61-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Jun2022, outcome "recovering" and all described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2021) Negative, notes: Patient previously had a negative COVID-19 test result on 20May2021; (28Jun2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective
Clinical narrative: Patient contracted COVID-19 while traveling, but not experiencing any symptom; Patient contracted COVID-19 while traveling, but not experiencing any symptom; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), ASYMPTOMATIC COVID-19 (medically significant), outcome "unknown" and all described as "Patient contracted COVID-19 while traveling, but not experiencing any symptom". Consumer male in 40s, weight and height unknown. Consumer has been vaccinated with Comirnaty and received booster. Patient contracted COVID-19 while traveling, but not experiencing any symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: always sick; Initial information received on 24-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who was always sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.Lot number cannot be requested.  On an unknown date the patient developed a non-serious event "always sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported" I took flu shots for years and was always sick; I stopped 18 years ago and have never been healthier."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (always sick).  At time of reporting, the outcome was Unknown for the event always sick.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt takes cetrizin 10mg
Age: 56.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: pt takes cetrzin 10 mg