chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Myelitis transverse, Plasma cell count, Protein total, Treponema test
Clinical narrative: TM (LETM); This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cervical cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "TM (LETM)". The patient underwent the following laboratory tests and procedures: antibody test: negative; autoantibody test: negative; blood glucose: normal; investigation: negative; negative; normal; negative; normal; normal; magnetic resonance imaging: extensive t2 signal abnormalities seen, notes: particularly in the anterior aspect, as well as the midcord extending from C3- 4 down to T2-3; magnetic resonance imaging head: normal; plasma cell count: normal; protein total: normal; treponema test: negative; viral test: negative. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information available, the causal relationship between the reported events 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: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: TM (LETM); This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cervical cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "TM (LETM)". The patient underwent the following laboratory tests and procedures: antibody test: negative; autoantibody test: negative; blood glucose: normal; investigation: negative; negative; normal; negative; normal; normal; magnetic resonance imaging: extensive t2 signal abnormalities seen, notes: particularly in the anterior aspect, as well as the midcord extending from C3- 4 down to T2-3; magnetic resonance imaging head: normal; plasma cell count: normal; protein total: normal; treponema test: negative; viral test: negative. Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on the information available, the causal relationship between the reported events 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
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: She stated it hurt a lot yesterday; Booster; lump underneath the site of the injection; itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALIUM taken for lower limb fracture; GABAPENTIN taken for lower limb fracture. Vaccination history included: Bnt162b2 (Dose 1, she was taking a muscle relaxer, Valium and gabapentin for her leg), administration date: Mar2021, for Covid-19 immunization, reaction(s): "She broke her leg severely in Sep"; Bnt162b2 (Dose 2, she was taking a muscle relaxer, Valium and gabapentin for her leg), administration date: Apr2021, for Covid-19 immunization, reaction(s): "She broke her leg severely in Sep". The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (non-serious) with onset Jan2022, outcome "unknown", described as "lump underneath the site of the injection"; VACCINATION SITE PRURITUS (non-serious) with onset Jan2022, outcome "unknown", described as "itchy"; VACCINATION SITE PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "She stated it hurt a lot yesterday".  Additional information: She broke her leg severely in September. Now she was taking a muscle relaxer, Valium, and gabapentin for her leg. She stated she has not had a reaction in the past so she was not sure if she should take those medications today. The caller stated she had her 3rd dose of the Pfizer-BioNTech COVID-19 vaccine and it was a little sore.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Peripheral swelling, Suspected COVID-19
Clinical narrative: highly exposed to Delta Variant.; highly exposed to Delta Variant.; after the first dose (Dec2020) and second dose of the Pfizer vaccine the patient experienced a severe swelling of her hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single 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 "highly exposed to Delta Variant."; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "after the first dose (Dec2020) and second dose of the Pfizer vaccine the patient experienced a severe swelling of her hands and feet".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Immune complex assay, SARS-CoV-2 antibody test, SARS-CoV-2 test, Therapeutic response delayed
Clinical narrative: Delayed immune response; This is a literature report. A 29 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), intramuscular (Batch/Lot number: unknown) as right deltoid region for tetanus immunisation. Relevant medical history included: "acne vulgaris" (ongoing). Concomitant medication(s) included: DOXYCYCLINE taken for acne; SPIRONOLACTONE taken for acne; DAPSONE taken for acne. Vaccination history included: Bnt162b2 (dose 1, intramuscular injection into the left deltoid region), administration date: Dec2020, for Covid 19 immunisation, reaction(s): "Fall/wound"; Bnt162b2 (dose 1, intramuscular injection into the left deltoid region), administration date: Dec2020, for COVID-19 immunisation, reaction(s): "Fall/wound". The following information was reported: THERAPEUTIC RESPONSE DELAYED (medically significant), outcome "recovered", described as "Delayed immune response". The patient underwent the following laboratory tests and procedures: immune complex assay: protective post-vaccination antibody levels, notes: immunoassay for tetanus; protective post-vaccination antibody levels, notes: immunoassay for diphtheria; sars-cov-2 antibody test: it was positive for antibodies to the spike (s1), notes: protein of the SARS-CoV-2 virus. repeat serological testing was done using this assay at day 57 after the completion her COVID-19 vaccination series; significant for negative igm and negative igg to, notes: the Spike (S1) protein of the SARS-CoV-2 virus. (Sensitivity 100%, Specificity 100%); sars-cov-2 test: negative, notes: Additional serological testing.  Information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events THERAPEUTIC RESPONSE DELAYED and the vaccine (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.",Linked Report(s) : US-PFIZER INC-202101883226 same article/drug/patient;different event
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood immunoglobulin G, Blood test
Clinical narrative: Severe autoimmune hemolytic anemia; This is a literature report  A 84 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant), outcome "unknown", described as "Severe autoimmune hemolytic anemia". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: positive; blood test: negative. Therapeutic measures were taken as a result of autoimmune haemolytic anaemia.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported event 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.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Myocarditis, Pericarditis, SARS-CoV-2 test
Clinical narrative: Myocarditis; Pericarditis; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: 330308D) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's -hypothyroidism" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 19Apr2021, when the patient was 36 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176), administration date: 10May2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 14Dec2021 21:00, outcome "unknown", described as "Booster"; MYOCARDITIS (hospitalization, medically significant) with onset 16Dec2021 21:00, outcome "recovered with sequelae", described as "Myocarditis"; PERICARDITIS (hospitalization, medically significant) with onset 16Dec2021 21:00, outcome "recovered with sequelae", described as "Pericarditis". The patient was hospitalized for immunisation, myocarditis, pericarditis (hospitalization duration: 1 day(s)). The events "booster", "myocarditis" and "pericarditis" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) negative, notes: Nasal Swab; (17Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of myocarditis, pericarditis. Clinical course: Treatment received for the adverse event are metoprolol and colchicine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received levothyroxine within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, Patient been tested for COVID-19. No Known allergies reported.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Immunisation, Pain, Pyrexia
Clinical narrative: noticed a darkened urine color and still its happening; Fever & Body pain - almost gone; Fever & Body pain - almost gone; dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 18:45 (Lot number: FL3209) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0182, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07May2021, when the patient was 32 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 16Apr2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 18:45, outcome "unknown", described as "dose number 3"; CHROMATURIA (non-serious) with onset 05Jan2022 19:15, outcome "not recovered", described as "noticed a darkened urine color and still its happening"; PYREXIA (non-serious), PAIN (non-serious) all with onset 05Jan2022 19:15, outcome "recovering" and all described as "Fever & Body pain - almost gone". Therapeutic measures were not taken as a result of chromaturia. Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was getting following side effects or events after 3rd COVID-19 Vaccine Pfizer BioNTech. The patient noticed a darkened urine color and it still was happening. The patient had fever and body pain - almost gone. The patient took 2 times Tylenol. The patient had no other medical issue and no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Left breast has been achy and had pain for a month and a half; The lymphnodes seem to be swollen in my left breast area; Inflammation; Discomfort hasn't been constant; dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: 363080) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Varicose Veins is all" (unspecified if ongoing), notes: Verbatim: Varicose Veins is all. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left), administration date: 10May2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Sore in my left arm"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left), administration date: 19Apr2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Sore in my left arm". The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "dose received: 3"; BREAST PAIN (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "Left breast has been achy and had pain for a month and a half"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "recovering", described as "The lymphnodes seem to be swollen in my left breast area"; INFLAMMATION (non-serious) with onset 23Nov2021, outcome "recovering", described as "Inflammation"; DISCOMFORT (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Discomfort hasn't been constant". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of breast pain, lymphadenopathy, inflammation, discomfort.  Adverse event: She did not have any side effects, and was hardly even sore in her left arm after the first two doses. But the day after she got her booster, right on time: Left breast has been achy and had pain for a month and a half. The left side of her breast, and what feels like inside her breast. It has hurted to sleep on that side to the point that she have not this until recent, when getting a lymphatic drainage session helped. The discomfort has not been constant, but has been a lot of the time, and even she massaged that area has not resolved. The lymphnodes seem to be swollen in her left breast area, and therefore things aren't moving along as they should and there is inflammation. It is concerning. Adverse event treatment was reported as Lymphatic drainage. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. No known allergies and other medical history reported at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got Covid; Got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 (Lot number: FH8028) at the age of 35 years as dose 3 (booster), single, administered in arm left, administration date 25Apr2021 (Lot number: ER8735) as dose 2 single and administration date 04Apr2021 (Lot number: ER8737) as dose 1 single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient did not received any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jan2022, outcome "recovering" and all described as "Got Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Device Date : 07Jan2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I contracted Covid; I contracted Covid; Dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 (Lot number: FH8028) at the age of 58 years as dose 3 (booster), single, administered in arm left, administration date 16Mar2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 22Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM; HYDROXYCHLOROQUINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovered" and all described as "I contracted Covid"; IMMUNISATION (medically significant) with onset 15Nov2021, outcome "unknown", described as "Dose_number=3". The event "i contracted covid" and "i contracted covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical course: Patient had no known allergies. Since the vaccination the patient has been tested for COVID-19. Patient did not receive any other vaccines in 4 weeks and prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: dose number=3; Tested positive for Covid on at home test; Tested positive for Covid on at home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose number=3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Tested positive for Covid on at home test". The event "tested positive for covid on at home test" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Other. Therapeutic measures were taken as a result of covid-19.  Additional information: The patient had not received any other vaccine within 4 weeks and medications within 2 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested positive since the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (manufacturer unknown), Mar 2021 and Apr 2021, for COVID-19 immunization. The patient had pain/it was a little sore, with outcome of unknown. The lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: showing symptoms of COVID-19; showing symptoms of COVID-19; exposed to COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1 (tris), single 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 "showing symptoms of COVID-19"; EXPOSURE TO SARS-COV-2 (non-serious), outcome "unknown", described as "exposed to COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown.  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-202200027212 Same drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: received 3 total doses of the Pfizer COVID-19 vaccine; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "received 3 total doses of the Pfizer COVID-19 vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. 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-202200027211 Same drug, different patient/AE;US-PFIZER INC-202200026534 Same drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Multisystem inflammatory syndrome, SARS-CoV-2 test
Clinical narrative: Multisystem Inflammatory Syndrome; had evidence of infection with a positive anti-nucleocapsid antibody test; had evidence of infection with a positive anti-nucleocapsid antibody test; This is a literature report  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (medically significant), outcome "unknown", described as "Multisystem Inflammatory Syndrome"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had evidence of infection with a positive anti-nucleocapsid antibody test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; negative, notes: NAAT was negative.  Clinical information: Patient reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) Aged 12-20 Years Who Received COVID-19 Vaccine, Dec2020 through Aug2021  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 known safety profile and Limited information in the case report a casual association between events multisystem inflammatory syndrome, drug ineffective and COVID-19 with the suspect product  bnt162b2and 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough infection; Breakthrough infection/ COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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) with onset 2021, outcome "unknown", described as "Breakthrough infection"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "Breakthrough infection/ COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical Course: It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the patient was diagnosed with COVID-19 prior to vaccination, but was tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough infection; Breakthrough infection/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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", described as "Breakthrough infection"; COVID-19 (medically significant), outcome "unknown", described as "Breakthrough infection/COVID-19 confirmed by positive COVID-19 test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical Course: It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the patient was diagnosed with COVID-19 with Covid-19 prior to vaccination, but was tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough infection; Breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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 "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: if covid tested post vaccination: Yes. It was unknown if 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary bladder haemorrhage
Clinical narrative: suddenly without any symptoms the patient was squeezing quarter sized clots from bladder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 13:15 (Lot number: ew0173) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: URINARY BLADDER HAEMORRHAGE (medically significant) with onset 16May2021, outcome "unknown", described as "suddenly without any symptoms the patient was squeezing quarter sized clots from bladder". The event "suddenly without any symptoms the patient was squeezing quarter sized clots from bladder" was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of urinary bladder haemorrhage.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea, Vaginal haemorrhage
Clinical narrative: Two hours after receiving vaccine heavy vaginal bleeding occurred for several days.; heavy, unscheduled and severely prolonged periods; heavy, unscheduled and severely prolonged periods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jun2021 (Lot number: EW0187) at the age of 28 years as dose 1, single and administered in arm left, administration date 19Jul2021 (Lot number: EW0187) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 28Jun2021, outcome "not recovered", described as "Two hours after receiving vaccine heavy vaginal bleeding occurred for several days."; HEAVY MENSTRUAL BLEEDING (medically significant), POLYMENORRHOEA (medically significant) all with onset 28Jun2021, outcome "not recovered" and all described as "heavy, unscheduled and severely prolonged periods". The events "two hours after receiving vaccine heavy vaginal bleeding occurred for several days.", "heavy, unscheduled and severely prolonged periods" and "heavy, unscheduled and severely prolonged periods" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vaginal haemorrhage, heavy menstrual bleeding, polymenorrhoea. Clinical course: First dose of Pfizer vaccine lot #EW0187 on 28Jun2021. Two hours after receiving vaccine heavy vaginal bleeding occurred for several days. Her normal and scheduled menstrual cycle had already ended for the month on 13Jun2021. Since this first vaccine, she had heavy, unscheduled, and severely prolonged periods. Lasting up to 3 weeks at a time every single month since being vaccinated. Her physician has advised to monitor due to the vaccine being new and not all is known about what to expect long term in adverse reactions to the body.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Spinal pain, Spondylitis, Uveitis
Clinical narrative: Uveitis; Full body inflammation, especially along spine; Full body inflammation, especially along spine; Joint pain; Spine pain; 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 (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (Lot number: ER8732) at the age of 37 years as dose 1, single and administration date 14Apr2021 (Lot number: ER0729) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Latex allergy/Nitrile allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: UVEITIS (medically significant) with onset 2021, outcome "not recovered", described as "Uveitis"; INFLAMMATION (non-serious), SPONDYLITIS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Full body inflammation, especially along spine"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Joint pain"; SPINAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Spine pain". The events "uveitis", "full body inflammation, especially along spine", "full body inflammation, especially along spine", "joint pain" and "spine pain" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uveitis, inflammation, spondylitis, arthralgia, spinal pain. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Immunisation, Orthostatic hypotension, Syncope
Clinical narrative: fainting; after any time the patient stood up, the blood pressure dropped/blood pressure still drops when standing up/low blood pressure; dizzy and lightheaded; 3rd dose (booster); This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  An 18-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 06Jan2022 12:45 (lot number FJ1611) at the age of 18-years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was reported as "none". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 2, lot number EW0177, location of injection: arm left), administration date: 21May2021, when the patient was 17 years old, for COVID-19 immunization, reaction: "inappropriate schedule of product administration"; and Bnt162b2 (dose 1, lot number EW0176), administration date: 06May2021, when the patient was 17 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Jan2022 12:45, outcome "unknown", described as "3rd dose (booster)"; SYNCOPE (medically significant) with onset 07Jan2022 04:00, outcome "recovering", described as "fainting"; ORTHOSTATIC HYPOTENSION (non-serious) with onset 07Jan2022 04:00, outcome "not recovered", described as "after any time the patient stood up, the blood pressure dropped/blood pressure still drops when standing up/low blood pressure"; DIZZINESS (non-serious) with onset 07Jan2022 04:00, outcome "recovered" (08Jan2022 16:00), described as "dizzy and lightheaded". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (07Jan2022) low; (07Jan2022) dropped. Clinical course: Approximately "14 hours" (as reported) after the 3rd dose (booster), the patient experienced a fainting episode and low blood pressure. For several hours, after any time the patient stood up, the blood pressure dropped, and the patient was dizzy and lightheaded. 36 hours later, the dizziness has stopped but the blood pressure still drops when standing up but not as much as earlier. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient has not been tested for covid-19.  Follow-up (11Jan2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200028847 same patient, different vaccine dose/AE
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pharyngeal swelling, Throat tightness, Urticaria
Clinical narrative: Swollen/closing throat; Swollen/closing throat; hives; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 15:00 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE. The patient had known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccine.  The following information was reported: THROAT TIGHTNESS (medically significant), PHARYNGEAL SWELLING (non-serious) all with onset 08Jan2022, outcome "recovering" and all described as "Swollen/closing throat"; DIARRHOEA (non-serious) with onset 07Jan2022 17:00, outcome "recovering", described as "diarrhea"; URTICARIA (non-serious) with onset 08Jan2022, outcome "recovering", described as "hives". Therapeutic measures were not taken as a result of throat tightness, pharyngeal swelling, diarrhoea, urticaria. Since the vaccination the patient was not tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Uterine haemorrhage
Clinical narrative: miscarriage; Bleeding from uterus; 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 (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Aug2021 11:00 (Lot number: FC3192) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time:, Date: 07Aug2021, Time: 14:00, Anatomical Site of injection: left site Deltoid, Route of administration: intramuscular, Batch/Lot Number: FA7485), administration date: 07Aug2021, when the patient was 37 years old, for Covid-19 Immunization, reaction(s): "Bleeding from uterus". The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 03Sep2021, outcome "unknown", described as "miscarriage"; UTERINE HAEMORRHAGE (medically significant) with onset 28Aug2021 14:00, outcome "recovered", described as "Bleeding from uterus". The events "miscarriage" and "bleeding from uterus" were evaluated at the physician office visit. Therapeutic measures were taken as a result of uterine haemorrhage.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: First grand mal seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 19 years as dose 2, single for covid-19 immunisation at a pharmacy or drug store. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Nov2020, when the patient was 19 years old, for Covid-19 Immunization. Clinical Course: The patient had her first grand mal seizure almost 3 weeks after her 2nd COVID-19 vaccine dose.  Her seizures began in early Feb2021. She has had several more since and the cause was unknown. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (hospitalization, medically significant) with onset Feb2021, outcome "not recovered", described as "First grand mal seizure". The patient was hospitalized for generalised tonic-clonic seizure (hospitalization duration: 3 day(s)). The event "first grand mal seizure" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of generalised tonic-clonic seizure included unspecified seizure medication and monitoring.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient later tested positive for covid.; The patient later tested positive for covid.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "The patient later tested positive for covid.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Lymphadenopathy, Myalgia, Spleen disorder
Clinical narrative: Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; Swollen spleen severe left sided pain; muscle aches; lymph glands swollen left axillary large and very painful; lymph glands swollen left axillary large and very painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 14:30 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies : Penicillin " (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious), SPLEEN DISORDER (non-serious), SWELLING (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Swollen spleen severe left sided pain"; MYALGIA (non-serious) with onset 02Jan2022, outcome "not recovered", described as "muscle aches"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "lymph glands swollen left axillary large and very painful". The events "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "swollen spleen severe left sided pain", "muscle aches", "lymph glands swollen left axillary large and very painful" and "lymph glands swollen left axillary large and very painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of abdominal pain, spleen disorder, swelling, myalgia, lymphadenopathy, axillary pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.