chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Physical examination, Polymerase chain reaction, Respiratory viral panel, SARS-CoV-2 test, Urine analysis
Clinical narrative: reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine; This is a literature report.  A 12-year-old otherwise-healthy female patient presented with painful vulvar ulcerations that had been present for approximately 5 days. Review of systems was positive for dysuria and hematuria. She was initially evaluated by her pediatrician and empirically treated with oral nitrofurantoin, fluconazole, and phenazopyridine for suspected urinary tract infection. She was then referred to pediatric dermatology for further evaluation and treatment due to lack of improvement. She was otherwise healthy and was not taking any other medications, denied any history of sexual activity, and had no previous history of oral ulcers, inflammatory bowel disease, or autoimmune disease. The family reported that the patient had received her second dose of the Pfizer-BioNTech SARS-CoV-2 vaccine approximately 48 hours before symptom onset. The day following vaccination, she also developed subjective fevers, fatigue, and malaise lasting 24 hours. On physical examination, there were approximately 2 _ 2-cm well-circumscribed, shallow ulcers with yellowish sloughing and purulent exudate on opposing surfaces of the bilateral labia minorae. Significant labial edema was present. Her oral mucosae were clear. Laboratory findings were notable for normal complete blood count and comprehensive metabolic panel and negative urine culture. Urinalysis demonstrated large leukocyte esterase, 20-29 white blood cells per high-power field, and moderate mucus. Lesional herpes simplex virus (HSV)-1 and HSV-2 polymerase chain reaction (PCR), Trichomonas/Gardnerella/Candida DNA probe, EBV antibody panel, respiratory viral panel, and SARS-CoV-2 PCR were negative. These clinical and laboratory findings were supportive of the diagnosis of reactive acute genital ulceration triggered by the SARS-CoV-2 vaccine. The patient was given topical clobetasol 0.05% ointment twice daily, lidocaine 2% jelly every 4-6 hours as needed, oral acetaminophen and ibuprofen as needed, and sitz baths with improvement of her symptoms. Ulcers healed over the course of 2 weeks.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported event Genital ulceration cannot be completely excluded based on temporal association and known drug safety profile 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-202200948342 Same article/drug/event and different patient (Patient 2);
Sex: U
Vaccine: PNC20
Symptoms: Thyroid cancer
Clinical narrative: I had thyroid cancer and I have no thyroid; The initial case was missing the following minimum criteria: [unspecified product]. Upon receipt of follow-up information on [14Jul2022], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID CANCER (medically significant), outcome "unknown", described as "I had thyroid cancer and I have no thyroid".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Your vaccine & 2 boosters made me very sick; 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) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Your vaccine & 2 boosters made me very sick". 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, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Your vaccine sucks is not effective; Your vaccine sucks is not effective; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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 "Your vaccine sucks is not effective". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19 once after the second dose and then following the booster; had COVID-19 once after the second dose and then following the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "had COVID-19 once after the second dose and then following the booster".  Additional information: Respondent received the Comiranty vaccine and booster and then had COVID-19 once after the second dose and then following the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19 once after the second dose and then following the booster; had COVID-19 once after the second dose and then following the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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 "had COVID-19 once after the second dose and then following the booster". Clinical Course: It was reported that patient received the Comirnaty vaccine and booster and then had COVID-19 once after the second dose and then following the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, CSF protein, CSF test, Encephalopathy, Fungal test
Clinical narrative: acute encephalopathy; seizures; This is a literature report.  A 69-year-old female patient 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: ENCEPHALOPATHY (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "acute encephalopathy"; SEIZURE (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "seizures". The patient underwent the following laboratory tests and procedures: Bacterial test: negative; CSF protein: 135 mg/dl; CSF test: revealed an elevated protein level (135 mg/dl); Fungal test: negative; HIV test: negative; autoimmune encephalitis panels: negative; negative; Magnetic resonance imaging head: showed gyriform-pattern diffusion restriction in t, notes: the right hemisphere and left frontoparietal region without features suggestive of an acute vascular event; showed similar findings to her previous scan with, notes: the addition of Wallerian degeneration in the right cerebral peduncle; Mycobacterium test: negative; SARS-CoV-2 antibody test: negative, notes: on post-immunization day 8; SARS-CoV-2 test: negative; Treponema test: negative; Vascular imaging: normal; Viral test: negative. Therapeutic measures were taken as a result of encephalopathy, seizure which includes empiric methylprednisolone and meningitis antibiotic/antiviral treatment  Clinical Course: Patient received her first dose of BNT162b2 five days prior, was found unresponsive. Within twenty-four hours of arrival, she developed focal seizures with secondary generalized, and remained in non-convulsive status epilepticus on longterm EEG monitoring until day 5 of admission despite three anti-seizure medications and a propofol drip. There was no significant improvement with treatment empiric methylprednisolone and meningitis antibiotic/antiviral treatment. She was discharged in a deeply comatose status on day 30 of hospital admission. Repeat MRI brain on day 14 showed similar findings to her previous scan with the addition of Wallerian degeneration in the right cerebral peduncle.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2 and the reported events encephalopathy, seizure 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Investigation, Magnetic resonance imaging head, Mycobacterium test, SARS-CoV-2 antibody test
Clinical narrative: acute encephalopathy; seizures; This is a literature report.  A 69-year-old female patient 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: ENCEPHALOPATHY (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "acute encephalopathy"; SEIZURE (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "seizures". The patient underwent the following laboratory tests and procedures: Bacterial test: negative; CSF protein: 135 mg/dl; CSF test: revealed an elevated protein level (135 mg/dl); Fungal test: negative; HIV test: negative; autoimmune encephalitis panels: negative; negative; Magnetic resonance imaging head: showed gyriform-pattern diffusion restriction in t, notes: the right hemisphere and left frontoparietal region without features suggestive of an acute vascular event; showed similar findings to her previous scan with, notes: the addition of Wallerian degeneration in the right cerebral peduncle; Mycobacterium test: negative; SARS-CoV-2 antibody test: negative, notes: on post-immunization day 8; SARS-CoV-2 test: negative; Treponema test: negative; Vascular imaging: normal; Viral test: negative. Therapeutic measures were taken as a result of encephalopathy, seizure which includes empiric methylprednisolone and meningitis antibiotic/antiviral treatment  Clinical Course: Patient received her first dose of BNT162b2 five days prior, was found unresponsive. Within twenty-four hours of arrival, she developed focal seizures with secondary generalized, and remained in non-convulsive status epilepticus on longterm EEG monitoring until day 5 of admission despite three anti-seizure medications and a propofol drip. There was no significant improvement with treatment empiric methylprednisolone and meningitis antibiotic/antiviral treatment. She was discharged in a deeply comatose status on day 30 of hospital admission. Repeat MRI brain on day 14 showed similar findings to her previous scan with the addition of Wallerian degeneration in the right cerebral peduncle.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2 and the reported events encephalopathy, seizure 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Treponema test, Vascular imaging, Viral test
Clinical narrative: acute encephalopathy; seizures; This is a literature report.  A 69-year-old female patient 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: ENCEPHALOPATHY (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "acute encephalopathy"; SEIZURE (hospitalization, medically significant), 5 days after the suspect product(s) administration, outcome "not recovered", described as "seizures". The patient underwent the following laboratory tests and procedures: Bacterial test: negative; CSF protein: 135 mg/dl; CSF test: revealed an elevated protein level (135 mg/dl); Fungal test: negative; HIV test: negative; autoimmune encephalitis panels: negative; negative; Magnetic resonance imaging head: showed gyriform-pattern diffusion restriction in t, notes: the right hemisphere and left frontoparietal region without features suggestive of an acute vascular event; showed similar findings to her previous scan with, notes: the addition of Wallerian degeneration in the right cerebral peduncle; Mycobacterium test: negative; SARS-CoV-2 antibody test: negative, notes: on post-immunization day 8; SARS-CoV-2 test: negative; Treponema test: negative; Vascular imaging: normal; Viral test: negative. Therapeutic measures were taken as a result of encephalopathy, seizure which includes empiric methylprednisolone and meningitis antibiotic/antiviral treatment  Clinical Course: Patient received her first dose of BNT162b2 five days prior, was found unresponsive. Within twenty-four hours of arrival, she developed focal seizures with secondary generalized, and remained in non-convulsive status epilepticus on longterm EEG monitoring until day 5 of admission despite three anti-seizure medications and a propofol drip. There was no significant improvement with treatment empiric methylprednisolone and meningitis antibiotic/antiviral treatment. She was discharged in a deeply comatose status on day 30 of hospital admission. Repeat MRI brain on day 14 showed similar findings to her previous scan with the addition of Wallerian degeneration in the right cerebral peduncle.  The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2 and the reported events encephalopathy, seizure 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Pyrexia, Suspected COVID-19
Clinical narrative: Respondent's husband received the Comiranty vaccine and then he contracted COVID-19; Respondent's husband received the Comiranty vaccine and then he contracted COVID-19; had a high fever for 5 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Respondent's husband received the Comiranty vaccine and then he contracted COVID-19"; PYREXIA (non-serious), outcome "unknown", described as "had a high fever for 5 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. 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: HERPES ZOSTER (non-serious) with onset Apr2021, outcome "unknown", described as "shingles". Additional information: The patient experienced shingles 3 days after her 2nd vaccination of Comirnaty. She received a booster shot Nov2021 and did not have shingles then. 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: Dyspnoea exertional
Clinical narrative: shortness of breath that occurs with exertion; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 90108767 (Agency).  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 following information was reported: DYSPNOEA EXERTIONAL (medically significant), outcome "not recovered", described as "shortness of breath that occurs with exertion". Therapeutic measures were taken as a result of dyspnoea exertional.  Clinical course: Patient called to report a product quality issue, also reported that "about a year ago" she received the COVID vaccine and experienced a severe reaction to it which left her with shortness of breath that occurs with exertion. Patient stated that she was a very active person and did not have these problems prior to the vaccine. Patient was prescribed Asmanex Twisthalers for the shortness of breath and stated that she had several of these inhalers malfunction in the past (exact date unknown) where they "are difficult to twist." She did not call to report this issue at that time because she "was a nurse", Patient stated that these inhalers did work well at helping manage her shortness of breath but she did experience this symptom if she misses a dose. Patient did not provide any further details or information related to this event.  No additional AE reported. No additional PQC reported. There are no product to retrieve as these inhalers have been discarded. Treatment provided: Product: Asmanex Twisthaler Powder 110 mcg , Dose/frequency: 2 puffs a day, Product: COVID Vaccine.  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 in the case report, a possible causal relationship between 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: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID; COVID; 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-163-4463628-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, citrate free, subcutaneous for rheumatoid arthritis. 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 "recovering" and all described as "COVID". The action taken for adalimumab was unknown. The elderly female patient experienced an event of non-serious COVID with Humira (Adalimumab). On an unknown date, the patient experienced COVID. Pfizer-BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter considered "covid" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility.  Causality for event COVID-19 (COVID-19) as per reporter with Humira was reported as not related. Causality for event COVID-19 (COVID-19) as per reporter with Pfizer-BioNTech Covid-19 Vaccine was reported as possible.  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 a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid19.
Sex: F
Vaccine: COVID19
Symptoms: Anti-muscle specific kinase antibody, Antibody test, Computerised tomogram head, Computerised tomogram thorax, Electromyogram
Clinical narrative: Myasthenia gravis; This is a literature report.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "sinus tachycardia" (unspecified if ongoing); "multiple hospitalizations" (unspecified if ongoing); "hospitalized" (unspecified if ongoing), notes: twice. The patient's concomitant medications were not reported. The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant, life threatening), 48 hrs after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Antibody test: negative; negative; Anti-muscle specific kinase antibody: negative; Computerised tomogram head: unrevealing; Computerised tomogram thorax: normal; Electromyogram: demonstrating moderate-to-severe electrical decrem, notes: ents in extremity and bulbar muscles; Serology test: negative, notes: MG; Spinal X-ray: unrevealing. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the available reported information, the causal association between the event myasthenia gravis and the 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: Myasthenia gravis, Serology test, Spinal X-ray
Clinical narrative: Myasthenia gravis; This is a literature report.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "sinus tachycardia" (unspecified if ongoing); "multiple hospitalizations" (unspecified if ongoing); "hospitalized" (unspecified if ongoing), notes: twice. The patient's concomitant medications were not reported. The following information was reported: MYASTHENIA GRAVIS (hospitalization, medically significant, life threatening), 48 hrs after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Antibody test: negative; negative; Anti-muscle specific kinase antibody: negative; Computerised tomogram head: unrevealing; Computerised tomogram thorax: normal; Electromyogram: demonstrating moderate-to-severe electrical decrem, notes: ents in extremity and bulbar muscles; Serology test: negative, notes: MG; Spinal X-ray: unrevealing. Therapeutic measures were taken as a result of myasthenia gravis.; Sender's Comments: Based on the available reported information, the causal association between the event myasthenia gravis and the 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: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis
Clinical narrative: Ankylosing spondylitis flare; 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-163-4463385-00 (Agency).  A 29-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 29 years intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Ankylosing spondylitis flare". The action taken for upadacitinib was unknown.  The reporter considered "ankylosing spondylitis flare" related 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 available information in the case, the causal association between the event Ankylosing spondylitis flare and the 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: Alopecia
Clinical narrative: Loosing my hair; 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 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: ALOPECIA (non-serious), outcome "unknown", described as "Loosing my hair".  Additional information: The patient was loosing hair because of COVID & the injections.  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: Antibody test, Antineutrophil cytoplasmic antibody, Biopsy kidney, Blood creatinine, Blood pressure measurement
Clinical narrative: pulmonary-renal syndrome; Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis; This is a literature report for the following literature source(s):.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "stage 3b chronic kidney disease" (ongoing); "cough" (unspecified if ongoing); "hemoptysis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY RENAL SYNDROME (hospitalization, medically significant, life threatening), outcome "unknown", described as "pulmonary-renal syndrome"; VASCULITIS (hospitalization, life threatening), outcome "unknown", described as "Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antineutrophil cytoplasmic antibody: positive; Antineutrophil cytoplasmic antibody (0.0-0.9): Greater than 8; negative; Biopsy kidney: focal necrotizing and crescentic glomerulonephriti, notes: focal necrotizing and crescentic glomerulonephritis and pauci-immune type MPO-ANCA seropositivity; Blood creatinine (normal low range 1.73): 4.56 mg/dl, notes: Baseline 1.73; Blood pressure measurement: 83/30 mmHg; Computerised tomogram thorax: patchy ground-glass and confluent airspace opaciti, notes: patchy ground-glass and confluent airspace opacities in both lungs; Haemoglobin: 9.1 g/dl; examination: he had pitting edema on the, notes: he had pitting edema on the lower extremities and scattered rhonchi and crackles on both lungs; Oxygen saturation: 77 %, notes: on ambient air; Protein urine: positive; Respiratory rate: 36; improved; Urine analysis: 21-50 red blood cells, and positive for protein; White blood cell count: 13.7. Therapeutic measures were taken as a result of pulmonary renal syndrome, vasculitis.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Haemoglobin, Investigation, Oxygen saturation, Protein urine
Clinical narrative: pulmonary-renal syndrome; Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis; This is a literature report for the following literature source(s):.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "stage 3b chronic kidney disease" (ongoing); "cough" (unspecified if ongoing); "hemoptysis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY RENAL SYNDROME (hospitalization, medically significant, life threatening), outcome "unknown", described as "pulmonary-renal syndrome"; VASCULITIS (hospitalization, life threatening), outcome "unknown", described as "Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antineutrophil cytoplasmic antibody: positive; Antineutrophil cytoplasmic antibody (0.0-0.9): Greater than 8; negative; Biopsy kidney: focal necrotizing and crescentic glomerulonephriti, notes: focal necrotizing and crescentic glomerulonephritis and pauci-immune type MPO-ANCA seropositivity; Blood creatinine (normal low range 1.73): 4.56 mg/dl, notes: Baseline 1.73; Blood pressure measurement: 83/30 mmHg; Computerised tomogram thorax: patchy ground-glass and confluent airspace opaciti, notes: patchy ground-glass and confluent airspace opacities in both lungs; Haemoglobin: 9.1 g/dl; examination: he had pitting edema on the, notes: he had pitting edema on the lower extremities and scattered rhonchi and crackles on both lungs; Oxygen saturation: 77 %, notes: on ambient air; Protein urine: positive; Respiratory rate: 36; improved; Urine analysis: 21-50 red blood cells, and positive for protein; White blood cell count: 13.7. Therapeutic measures were taken as a result of pulmonary renal syndrome, vasculitis.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary renal syndrome, Respiratory rate, Urine analysis, Vasculitis, White blood cell count
Clinical narrative: pulmonary-renal syndrome; Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis; This is a literature report for the following literature source(s):.  An 83-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "stage 3b chronic kidney disease" (ongoing); "cough" (unspecified if ongoing); "hemoptysis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY RENAL SYNDROME (hospitalization, medically significant, life threatening), outcome "unknown", described as "pulmonary-renal syndrome"; VASCULITIS (hospitalization, life threatening), outcome "unknown", described as "Anti-Neutrophil Cytoplasmic Antibody Associated Vasculitis". The patient underwent the following laboratory tests and procedures: Antibody test: negative; Antineutrophil cytoplasmic antibody: positive; Antineutrophil cytoplasmic antibody (0.0-0.9): Greater than 8; negative; Biopsy kidney: focal necrotizing and crescentic glomerulonephriti, notes: focal necrotizing and crescentic glomerulonephritis and pauci-immune type MPO-ANCA seropositivity; Blood creatinine (normal low range 1.73): 4.56 mg/dl, notes: Baseline 1.73; Blood pressure measurement: 83/30 mmHg; Computerised tomogram thorax: patchy ground-glass and confluent airspace opaciti, notes: patchy ground-glass and confluent airspace opacities in both lungs; Haemoglobin: 9.1 g/dl; examination: he had pitting edema on the, notes: he had pitting edema on the lower extremities and scattered rhonchi and crackles on both lungs; Oxygen saturation: 77 %, notes: on ambient air; Protein urine: positive; Respiratory rate: 36; improved; Urine analysis: 21-50 red blood cells, and positive for protein; White blood cell count: 13.7. Therapeutic measures were taken as a result of pulmonary renal syndrome, vasculitis.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Loss of personal independence in daily activities
Clinical narrative: Diagnosed with Covid in the ER; Diagnosed with Covid in the ER; Sick for approximately a week; Effected my ability to do most everything; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 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), COVID-19 (medically significant) all with onset 12May2022, outcome "unknown" and all described as "Diagnosed with Covid in the ER"; ILLNESS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "Sick for approximately a week"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Effected my ability to do most everything". The events "sick for approximately a week" and "effected my ability to do most everything" required physician office visit. The event "diagnosed with covid in the er" required emergency room visit. Clinical Course: I received my Pfizer vaccine around 01Mar2021. (I don't have my card on me as I type this.) On 12May2022 I was diagnosed with Covid in the ER. I had been sick for approximately a week prior to that. I am still experiencing very challenging symptoms since that time and have had Drs visits.It has effected my ability to do most everything. I don't know who to contact concerning possible follow up treatment. I appreciate any and all direction you can provide me. Thank you so much.   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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: On 21Jun My wife and I tested positive for Covid; On 21Jun My wife and I tested positive for 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 male patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (Batch/Lot number: unknown), as DOSE 2, SINGLE (Batch/Lot number: unknown), as DOSE 3 (booster), SINGLE (Batch/Lot number: unknown) and as DOSE 4 (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 21Jun2022, outcome "not recovered" and all described as "On 21Jun My wife and I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: On 21Jun My wife and I tested positive for Covid; (01Jul2022) Negative, notes: After 10 days We both tested negative; (02Jul2022) Positive, notes: On day 11 and 12, so far, I am testing positive; (03Jul2022) Positive, notes: On day 11 and 12, so far, I am testing positive; (08Jul2022) Positive, notes: Now I am on day 17 and still testing positive. Therapeutic measures were taken as a result of Drug ineffective, COVID-19.  Additional information: On 21Jun patient and his wife tested positive for Covid immediately went on Paxlovid for 5 days because of some existing health issues. On day 10 tested negative. On Day 11 patient retested and was positive. Now he was on day 17 and still testing 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: Acoustic stimulation tests, Computerised tomogram, Deafness, Magnetic resonance imaging, Tinnitus
Clinical narrative: On 21Jun My wife and I tested positive for Covid; On 21Jun My wife and I tested positive for 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 male patient received BNT162b2 (BNT162B2), as DOSE 1, SINGLE (Batch/Lot number: unknown), as DOSE 2, SINGLE (Batch/Lot number: unknown), as DOSE 3 (booster), SINGLE (Batch/Lot number: unknown) and as DOSE 4 (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 21Jun2022, outcome "not recovered" and all described as "On 21Jun My wife and I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: On 21Jun My wife and I tested positive for Covid; (01Jul2022) Negative, notes: After 10 days We both tested negative; (02Jul2022) Positive, notes: On day 11 and 12, so far, I am testing positive; (03Jul2022) Positive, notes: On day 11 and 12, so far, I am testing positive; (08Jul2022) Positive, notes: Now I am on day 17 and still testing positive. Therapeutic measures were taken as a result of Drug ineffective, COVID-19.  Additional information: On 21Jun patient and his wife tested positive for Covid immediately went on Paxlovid for 5 days because of some existing health issues. On day 10 tested negative. On Day 11 patient retested and was positive. Now he was on day 17 and still testing positive.  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: Glossodynia, Skin exfoliation
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for COVID-19 immunization. The following information was reported: SKIN EXFOLIATION (non-serious) with onset 2022, outcome "unknown", described as "caused severe sloughing on feet and hands"; GLOSSODYNIA (non-serious) with onset 2022, outcome "unknown", described as "residual tongue sensitivity". Additional Information:  Reporter provided verification of contact address on 13Jul2022 I had 2nd Pfizer vac. On 10Apr2022. Patient suffered a reaction that caused severe sloughing on feet and hands. patient also residual tongue sensitivity. patient concerned that patient don't any options for further protection from covid-19. CEP Number: CEP 005570 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: Imaging procedure, Investigation, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Longitudinal extensive transverse myelitis; This is a literature report.  A 17-year-old male patient 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: MYELITIS TRANSVERSE (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovering", described as "Longitudinal extensive transverse myelitis". The patient underwent the following laboratory tests and procedures: Imaging procedure: was consistent with acute onset longitudinally ext, notes: ensive transverse myelitis (LETM); broad autoimmune workup: all of which was non-diagnostic; all of which was non-diagnostic; all of which was non-diagnostic; all of which was non-diagnostic; Magnetic resonance imaging spinal: he was found to have edema and heterogenously hype, notes: rintense T2 signal involving the entirety of the spinal cord, most marked in the cervical and mid thoracic segments. The imaging was consistent with acute onset longitudinally extensive transverse myelitis (LETM). Therapeutic measures were taken as a result of myelitis transverse.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of Myelitis transverse.