chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Kaposi's sarcoma
Clinical narrative: Kaposi's sarcoma; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), administration date 04Feb2021 (Lot number: EL9261) at the age of 72 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Patient's family medical history was not provided. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: EK4176), administration date: 14Jan2021, for COVID-19 vaccination. The patient did not experienced events following prior vaccinations. The following information was reported: KAPOSI'S SARCOMA (medically significant) with onset 2021, outcome "unknown", described as "Kaposi's sarcoma". The event "kaposi's sarcoma" was evaluated at the physician office visit. Caller (patient) thought he might have had an adverse reaction. He saw a video that they did in a studio where someone interviewed people. He clarified it was like a news program, he didn't know which one it was but there was a study done where people got Kaposi sarcoma as side effects from the vaccine. Something must have happened to have gotten them. Caller states he didn't inform his doctor about the side effects yet (as reported). When probed to determine when Kaposi sarcoma was diagnosed, he explained the first one (lesion) was about 6 months before the present report. The second one (lesion) was removed about a week ago. He clarified later during the call they took it out more than week ago. He clarified he had a biopsy done and with the second one when he got the results, he was handed a piece of paper that said he had Kaposi sarcoma.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101772608 Same patient/drug and different dose/AEs.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Malaise, Pulmonary thrombosis
Clinical narrative: small blood clots in her lungs/blood clots; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 immunisation. The following information was reported: PULMONARY THROMBOSIS (medically significant) with onset 23Nov2021, outcome "unknown", described as "small blood clots in her lungs/blood clots"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well". The patient reported that she received the Pfizer vaccine both 1 and 2 and ended up getting blood clots. She reported she wasn't feeling well, and they did a computerised tomogram (CAT) scan on her and found the clots. The patient reported she never had any clots until she had that vaccine. She believed the blood clots where caused by the Pfizer vaccine that she received in early 2021 when older people where first allowed to get the vaccine. She then developed the blood clots that she believed where caused by the Pfizer vaccine on 23-Nov-2021. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) clots. Therapeutic measures were taken as a result of pulmonary thrombosis. The patient reported that she started apixaban (ELIQUIS) for small blood clots in her lungs.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Headache, Immunisation
Clinical narrative: I couldn't breathe, I got breathing issue; Chills real bad; Real bad headache like almost a migraine headache; Real bad headache like almost a migraine headache; My body really achy, and it was shaky for a good half hour; My body really achy, and it was shaky for a good half hour; Booster; I am still weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 11:00 (Lot number: FJ8762) at the age of 65 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "I am taking heart medication" (unspecified if ongoing); "breathing" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:00, outcome "unknown", described as "Booster"; DYSPNOEA (non-serious) with onset 10Dec2021 08:15, outcome "unknown", described as "I couldn't breathe, I got breathing issue"; CHILLS (non-serious) with onset 09Dec2021 17:30, outcome "not recovered", described as "Chills real bad"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "Real bad headache like almost a migraine headache"; PAIN (non-serious), TREMOR (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "My body really achy, and it was shaky for a good half hour"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "I am still weak". Therapeutic measures were taken as a result of dyspnoea, pain.  Additional information: The patient took rescue inhaler for breathing issue eventually it got better and the patient could breath. The patient takes heart medication, medication for arthritis and also medication for their breathing. Patient was staying home and resting .   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pain, Tremor
Clinical narrative: I couldn't breathe, I got breathing issue; Chills real bad; Real bad headache like almost a migraine headache; Real bad headache like almost a migraine headache; My body really achy, and it was shaky for a good half hour; My body really achy, and it was shaky for a good half hour; Booster; I am still weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 11:00 (Lot number: FJ8762) at the age of 65 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "I am taking heart medication" (unspecified if ongoing); "breathing" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 11:00, outcome "unknown", described as "Booster"; DYSPNOEA (non-serious) with onset 10Dec2021 08:15, outcome "unknown", described as "I couldn't breathe, I got breathing issue"; CHILLS (non-serious) with onset 09Dec2021 17:30, outcome "not recovered", described as "Chills real bad"; HEADACHE (non-serious), MIGRAINE (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "Real bad headache like almost a migraine headache"; PAIN (non-serious), TREMOR (non-serious) all with onset 09Dec2021 17:30, outcome "unknown" and all described as "My body really achy, and it was shaky for a good half hour"; ASTHENIA (non-serious) with onset Dec2021, outcome "not recovered", described as "I am still weak". Therapeutic measures were taken as a result of dyspnoea, pain.  Additional information: The patient took rescue inhaler for breathing issue eventually it got better and the patient could breath. The patient takes heart medication, medication for arthritis and also medication for their breathing. Patient was staying home and resting .   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pericarditis
Clinical narrative: pericarditis/ Tightness/heaviness in chest/ shallow breathing; booster; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Dec2021 12:00 (Lot number: FH8030) at the age of 65 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). The patient had not had COVID-19 and she was not diagnosed with COVID-19 prior vaccination. There were no concomitant medications received within two weeks of vaccination. Past drug history included: Amoxicillin, reaction: "Allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 03Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 13Mar2021, when the patient was 64 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021 12:00, outcome "unknown", described as "booster"; PERICARDITIS (medically significant) with onset 09Dec2021 02:00, outcome "recovering", described as "pericarditis/ Tightness/heaviness in chest/ shallow breathing". The event "pericarditis/ tightness/heaviness in chest/ shallow breathing" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pericarditis and included prescription of indomethacin and colchicine. The patient had not been tested for COVID-19 since the vaccination. Clinical course: Tightness/heaviness in chest; shallow breathing. Diagnosed as pericarditis.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: possible pericarditis; chest pain; feeling tired; harder to breath than normal; irregular heartbeat; fever hovering at 102 for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications in two weeks. The patient did not receive any other vaccination within the four weeks before the vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The following information was reported: PERICARDITIS (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "possible pericarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "chest pain"; FATIGUE (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "feeling tired"; DYSPNOEA (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "harder to breath than normal"; HEART RATE IRREGULAR (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "irregular heartbeat"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever hovering at 102 for 3 days". The patient was hospitalized for pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular (hospitalization duration: 1 day(s)). The events "possible pericarditis", "chest pain", "feeling tired", "harder to breath than normal" and "irregular heartbeat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) irregular heartbeat; (unspecified date) irregular heartbeat; body temperature: (09Dec2021) 102; sars-cov-2 test: (09Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular, pyrexia. Clinical course: Child was taken in ambulance to hospital. Emergency medical technician (EMT) found irregular heartbeat on Electrocardiogram (EKG)/ Electrocardiogram (ECG). Same was found in hospital. Released with possible pericarditis and request to follow up with pediatrician for chest x-ray and covid test (which was negative). A week later, he had a fever hovering at 102 for 3 days. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Pericarditis, Pyrexia, SARS-CoV-2 test
Clinical narrative: possible pericarditis; chest pain; feeling tired; harder to breath than normal; irregular heartbeat; fever hovering at 102 for 3 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 09:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications in two weeks. The patient did not receive any other vaccination within the four weeks before the vaccination. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The following information was reported: PERICARDITIS (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "possible pericarditis"; CHEST PAIN (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "chest pain"; FATIGUE (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "feeling tired"; DYSPNOEA (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "harder to breath than normal"; HEART RATE IRREGULAR (hospitalization) with onset 16Nov2021 14:00, outcome "recovering", described as "irregular heartbeat"; PYREXIA (non-serious) with onset Nov2021, outcome "recovering", described as "fever hovering at 102 for 3 days". The patient was hospitalized for pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular (hospitalization duration: 1 day(s)). The events "possible pericarditis", "chest pain", "feeling tired", "harder to breath than normal" and "irregular heartbeat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (unspecified date) irregular heartbeat; (unspecified date) irregular heartbeat; body temperature: (09Dec2021) 102; sars-cov-2 test: (09Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pericarditis, chest pain, fatigue, dyspnoea, heart rate irregular, pyrexia. Clinical course: Child was taken in ambulance to hospital. Emergency medical technician (EMT) found irregular heartbeat on Electrocardiogram (EKG)/ Electrocardiogram (ECG). Same was found in hospital. Released with possible pericarditis and request to follow up with pediatrician for chest x-ray and covid test (which was negative). A week later, he had a fever hovering at 102 for 3 days. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Dizziness, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Severe ataxia; muscle weakness; dizziness; headaches; hand tremors; leg and arm pain; brain fog; numbness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 08:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa based medication allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ATAXIA (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "Severe ataxia"; MUSCULAR WEAKNESS (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "muscle weakness"; DIZZINESS (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "dizziness"; HEADACHE (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "headaches"; TREMOR (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "hand tremors"; PAIN IN EXTREMITY (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "leg and arm pain"; FEELING ABNORMAL (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "brain fog"; HYPOAESTHESIA (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "numbness". The patient was hospitalized for ataxia, muscular weakness, dizziness, headache, tremor, pain in extremity, feeling abnormal, hypoaesthesia (hospitalization duration: 1 day(s)). The events "severe ataxia", "muscle weakness", "dizziness", "headaches", "hand tremors", "leg and arm pain", "brain fog" and "numbness" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative; (16Nov2021) negative. Therapeutic measures were taken as a result of ataxia, muscular weakness, dizziness, headache, tremor, pain in extremity, feeling abnormal, hypoaesthesia which included Muscle relaxers, physical therapy. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, SARS-CoV-2 test, Tremor
Clinical narrative: Severe ataxia; muscle weakness; dizziness; headaches; hand tremors; leg and arm pain; brain fog; numbness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 08:30 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sulfa based medication allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ATAXIA (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "Severe ataxia"; MUSCULAR WEAKNESS (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "muscle weakness"; DIZZINESS (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "dizziness"; HEADACHE (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "headaches"; TREMOR (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "hand tremors"; PAIN IN EXTREMITY (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "leg and arm pain"; FEELING ABNORMAL (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "brain fog"; HYPOAESTHESIA (hospitalization, disability) with onset 05Nov2021, outcome "not recovered", described as "numbness". The patient was hospitalized for ataxia, muscular weakness, dizziness, headache, tremor, pain in extremity, feeling abnormal, hypoaesthesia (hospitalization duration: 1 day(s)). The events "severe ataxia", "muscle weakness", "dizziness", "headaches", "hand tremors", "leg and arm pain", "brain fog" and "numbness" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Nov2021) negative; (16Nov2021) negative. Therapeutic measures were taken as a result of ataxia, muscular weakness, dizziness, headache, tremor, pain in extremity, feeling abnormal, hypoaesthesia which included Muscle relaxers, physical therapy. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient stated she got her covid shot and it knocked her out for hours; This is a spontaneous report received from contactable reporter (Consumer) for a Pfizer sponsored program (134184). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: LYRICA. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Patient stated she got her covid shot and it knocked her out for hours".  Additional information: patient stated she can't go without her medicine (as reported). The lot number for bnt162b2 was not provided and will be requested during follow up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Dystonia
Clinical narrative: I have developed blepharospasm; possible cranial dystonia; This is a spontaneous report received from contactable reporter (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2021 (Lot number: El3302) at the age of 52 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient had no known allergies. The patient took concomitant medications (unspecified). The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.  Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. The following information was reported: BLEPHAROSPASM (disability) with onset 25Jan2021, outcome "not recovered", described as "I have developed blepharospasm"; DYSTONIA (disability) with onset 25Jan2021, outcome "not recovered", described as "possible cranial dystonia". The events "i have developed blepharospasm" and "possible cranial dystonia" were evaluated at the physician office visit. Therapeutic measures were taken as a result of blepharospasm, dystonia included botox injections.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Blepharospasm, Dystonia and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got a breakthrough COVID PCR+ infection; got a breakthrough COVID PCR+ infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (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), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got a breakthrough COVID PCR+ infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymph node pain, Lymphadenopathy
Clinical narrative: Ipsilateral supraclavicular lymph node swelling with associated pain; Ipsilateral supraclavicular lymph node swelling with associated pain; dose_number=3; This is a spontaneous report received from a contactable reporter(Physician). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19), intramuscular, administered in arm left, administration date 10Dec2021 09:00 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; IBUPROFEN. Past drug history included: Zantac, reaction(s): "known allergies: Zantac". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 09:00, outcome "unknown", described as "dose_number=3"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 11Dec2021, outcome "unknown" and all described as "Ipsilateral supraclavicular lymph node swelling with associated pain". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain. Additional Information: the patient did not received any other vaccine within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient had not been diagnosed with COVID-19,and Since the vaccination,patient had not been tested for  COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 with symptoms; Tested positive for COVID-19 with symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No underlying conditions/None" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization; Bnt162b2 (DOSE 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2021, outcome "unknown" and all described as "Tested positive for COVID-19 with symptoms"; IMMUNISATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) positive. It was reported that patient started with flu-like symptoms, and was tested positive for COVID-19 rapid-home test on previous night of this report. The patient had headache, runny nose, sneezing, fatigue, feeling weak, nausea, very mild cough and mild shortness of breath. The patient did not have fever.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid after receiving the vaccine; She tested positive for Covid after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Aug2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She tested positive for Covid after receiving the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Intraocular pressure test, Investigation, Necrotising retinitis, Optical coherence tomography, Visual acuity tests
Clinical narrative: Retinal Necrosis; This is a literature report.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chickenpox" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: NECROTISING RETINITIS (medically significant), outcome "unknown", described as "Retinal Necrosis". The patient underwent the following laboratory tests and procedures: intraocular pressure test: 53 mmHg; 16 to 23; investigation: notable for vitreous cells, occlusive retinal, notes: vasculitis, large  retinal hemorrhages, and three quadrants of peripheral areas of  retinal whitening; optical coherence tomography: demonstrated scattered vitreal debris,, notes: intraretinal edema, and areas of full thickness disruption of retinal architecture with increased hyperreflectivity; visual acuity tests: 20/125, notes: left eye.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Necrotising retinitis and BNT162B2.  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: Myocardial infarction
Clinical narrative: a recent cardiac event that they experienced (heart attack); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 2021, outcome "unknown", described as "a recent cardiac event that they experienced (heart attack)".  Clinical information: I overheard this conversation but I do not know who this individual is. It sounds like they were talking about a recent cardiac event that they experienced (heart attack). I think they were talking about just getting cleared for some activities - I think exercise. Since they were not wearing a mask in the building I think they are vaccinated, but I do not know the details like which vaccine, dose number, or how to confirm. Think they are of (Withheld) ethnicity and seemed older.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 21K-163-4188611-00.  A 40-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Route of Admin: 1)Intra-muscular), administration date: 05May2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, Route of Admin: 1)Intra-muscular), administration date: 04Nov2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 PNEUMONIA (medically significant), outcome "recovering" and all described as "COVID-19 pneumonia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: In 2021, the patient experienced Covid Pneumonia. The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter Causality for humira (adalimumab): for the event(s) of covid pneumonia was not reported. The reporter Causality for Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): for the event covid-19 pneumonia was not related. The event abate after stopping drug was: NA  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and known drug safety profile  the event of Drug ineffective , COVID-19 pneumonia was assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Renal function test, Renal impairment, Road traffic accident
Clinical narrative: Renal function abnormal; Automobile accident; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190167-00 (AbbVie).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL IMPAIRMENT (medically significant) with onset Dec2021, outcome "not recovered", described as "Renal function abnormal"; ROAD TRAFFIC ACCIDENT (non-serious) with onset Dec2021, outcome "not recovered", described as "Automobile accident". The patient underwent the following laboratory tests and procedures: renal function test: (Dec2021) abnormal. The action taken for adalimumab was unknown.  Clinical course: Solicited report by a consumer of an adult female with an event of non-serious car accident showed abnormal kidney with humira (adalimumab). There was no reported medical history. On an unknown date, the patient experienced car accident showed abnormal kidney. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 03Dec2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/biontech.  Causality for humira(adalimumab): The reporter's causality for the event(s) of car accident showed abnormal kidney and car accident showed abnormal kidney with humira(adalimumab) was no reasonable possibility.  Causality for Pfizer Biontech Covid-19 Vaccine: The reporter's causality for the event(s) of car accident showed abnormal kidney and car accident showed abnormal kidney with Pfizer Biontech Covid-19 Vaccine was possible.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,   possible causal relationship between the event Renal impairment and suspect drug BNT162B2 cannot be excluded.  Based on currently available limited information and nature of event ,Automobile accident is considered Unrelated. Case will be reassessed once more information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: her brother is already fully vaccinated however he got covid; her brother is already fully vaccinated however he got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "her brother is already fully vaccinated however he got covid". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021561520 same reporter, different patient/AE
Age: 45.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; MARKETTING PROGRAM NAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4191463-00 (Abbvie).  A 45 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Dec2020 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single and intramuscular, administration date 17Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up" related to bnt162b2. The reporter's causality for the event(s) of Rheumatoid Arthritis Flare Up with Humira(Adalimumab) was no reasonable possibility.  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 currently available information the possibility of causal association between the event Rheumatoid arthritis flare up and the suspect drug BNT162B2  is assessed as not related. The case will be reassessed once new information (event date) is available.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abscess intestinal, Crohn's disease, Nasopharyngitis
Clinical narrative: Abscess of intestine; Crohn's; Cold; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4189072-00 (AbbVie).  A 56 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABSCESS INTESTINAL (medically significant), outcome "not recovered", described as "Abscess of intestine"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's"; NASOPHARYNGITIS (medically significant) with onset Apr2021, outcome "recovered" (May2021), described as "Cold". The action taken for adalimumab was unknown.  Clinical information: Causality for HUMIRA (ADALIMUMAB). The reporter's causality for the event(s) of abscess in intestines, active crohn's, second dose of covid vaccine had fever and first covid vaccine felt like had mild cold was not provided. As per reporter Causality (Drug/Vaccine) for events Abscess of intestine, Crohn's disease was not reported and for cold was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events - Abscess intestinal, Crohn's disease, Nasopharyngitis and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer 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-202101780644 same reporter/patient/drug, different event and dose
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess intestinal, Crohn's disease, Pyrexia
Clinical narrative: Abscess In Intestines; Active Crohn's; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4189072-00.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Route of Adm: Intramuscular, Therapy dates/Duration: 01Apr2021 - 01Apr2021, On unknown dates, the patient experienced abscess in intestines and active crohn's, the first covid vaccine felt like had mild cold (from Apr2021 to Apr2021) resolved), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 Immunisation, reaction(s): "Abscess In Intestines", "Active Crohn's", "Mild cold". The following information was reported: ABSCESS INTESTINAL (medically significant), outcome "not recovered", described as "Abscess In Intestines"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Active Crohn's"; PYREXIA (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Fever". The action taken for adalimumab was unknown. Clinical course; Patient had abscess in intestines, active crohn's, second dose of covid vaccine had fever and first covid vaccine felt like had mild cold with humira (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality of events with bnt162b2 and adalimumab (HUMIRA) was not provided.  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 and a possible contributory role of suspect product BNT162B2 to the development of event pyrexia cannot be totally excluded and events abscess intestinal, crohn's disease mostly related to HUMIRA and not related to BNT162B2.,Linked Report(s) : US-PFIZER_INC-202101780643 same reporter/patient/drug, different event/dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation
Clinical narrative: uncomfortable with covid- had booster--as does family; uncomfortable with covid- had booster--as does family; uncomfortable with covid- had booster--as does family; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ANASTROZOLE; XGEVA. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective"; Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Covid", "Drug ineffective". The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "uncomfortable with covid- had booster--as does family". Patient was uncomfortable with covid- had booster--as does family; pandemic causes her stress.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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