chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pyrexia, Wheezing
Clinical narrative: Surgery on Shoulder; Hoarseness / hoarse voice; Coughing Spells; Fever; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FJ5682) at the age of 67 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (ongoing), notes: Well Controlled; "Asthma" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EL3249), administration date: 15Jan2021, for COVID-19 IMMUNIZATION; Bnt162b2 (Second dose, Lot: EL9264), administration date: 05Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Surgery on Shoulder"; DYSPHONIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Hoarseness / hoarse voice"; COUGH (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Coughing Spells"; PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever". Therapeutic measures were taken as a result of dysphonia included Tylenol and Robitussin, drinks warm water and lemon and ginger tea. Clinical course: The patient stated that she received her Booster dose last Wednesday and the following day she had a hoarse voice, some fever and coughing spells. She wants to know if losing your voice is a side effect of the booster dose because she never had this problem with the first two. It has been over a week now and she still feels the side effects. She is on Medical leave because she had surgery on her shoulder and so she hasn't been out, so why should she feel like this?    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Shoulder operation and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Dizziness, Fall, Heart rate
Clinical narrative: fell to the floor; shaking; feeling dizzy; stomach ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Jan2022 10:30 (Lot number: FLOOO7) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FALL (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "fell to the floor"; TREMOR (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "shaking"; DIZZINESS (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "feeling dizzy"; ABDOMINAL PAIN UPPER (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "stomach ache". The events "fell to the floor", "shaking", "feeling dizzy" and "stomach ache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fall, tremor, dizziness, abdominal pain upper.  Additional details: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient came for first Covid shot. Patient's mother denied any reaction in the past to other vaccines. Covid Vaccine was administered to his left arm. During 20 min of observation, patient started shaking and fell to the floor. MD came in right away and evaluated patient. Vital was taken. 127/56, 65hr, 100%. Patient reobserved for another 20 mins. Patient reported feeling dizzy again and stomach ache. Code MET was called patient transported to ER. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown if the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fell to the floor; shaking; feeling dizzy; stomach ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Jan2022 10:30 (Lot number: FLOOO7) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FALL (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "fell to the floor"; TREMOR (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "shaking"; DIZZINESS (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "feeling dizzy"; ABDOMINAL PAIN UPPER (non-serious) with onset 20Jan2022 10:30, outcome "unknown", described as "stomach ache". The events "fell to the floor", "shaking", "feeling dizzy" and "stomach ache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fall, tremor, dizziness, abdominal pain upper.  Additional details: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient came for first Covid shot. Patient's mother denied any reaction in the past to other vaccines. Covid Vaccine was administered to his left arm. During 20 min of observation, patient started shaking and fell to the floor. MD came in right away and evaluated patient. Vital was taken. 127/56, 65hr, 100%. Patient reobserved for another 20 mins. Patient reported feeling dizzy again and stomach ache. Code MET was called patient transported to ER. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown if the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Severe Migraines; Dizziness; Fatigue; Nausea; Chills; Severe Sweating; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) physician received via COVID-19 Adverse Event Self-Reporting. The reporter is the patient. A 30-year-old adult female patient (not pregnant) received bnt162b2 (BNT162B2, product=COVID 19, brand: Pfizer, brand unknown: False), administered in arm right, administration date 23Jun2021 (Lot number: EW0185, lot unknown: False) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Facility type Vaccine was unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was none Known allergies. Concomitant medication(s) included in two weeks: sertraline (ZOLOFT); bupropion (WELLBUTRIN). The following information was reported: MIGRAINE (disability) with onset Jul2021, outcome "not recovered", described as "Severe Migraines"; DIZZINESS (disability) with onset Jul2021, outcome "not recovered", described as "Dizziness"; FATIGUE (disability) with onset Jul2021, outcome "not recovered", described as "Fatigue"; NAUSEA (disability) with onset Jul2021, outcome "not recovered", described as "Nausea"; CHILLS (disability) with onset Jul2021, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (disability) with onset Jul2021, outcome "not recovered", described as "Severe Sweating"; DYSPNOEA (disability) with onset Jul2021, outcome "not recovered", described as "Shortness of breath". The events "severe migraines", "dizziness", "fatigue", "nausea", "chills", "severe sweating" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Adverse event:  Severe Migraines. Dizziness. Fatigue. Nausea. Chills and Severe Sweating. Shortness of breath after normal activities. Has not stopped since Jul2021. Ae resulted in: [Disability or permanent damage]. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was unknown if therapeutic measures were taken as a result of migraine, dizziness, fatigue, nausea, chills, hyperhidrosis, dyspnoea.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Severe Migraines; Dizziness; Fatigue; Nausea; Chills; Severe Sweating; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) physician received via COVID-19 Adverse Event Self-Reporting. The reporter is the patient. A 30-year-old adult female patient (not pregnant) received bnt162b2 (BNT162B2, product=COVID 19, brand: Pfizer, brand unknown: False), administered in arm right, administration date 23Jun2021 (Lot number: EW0185, lot unknown: False) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Facility type Vaccine was unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was none Known allergies. Concomitant medication(s) included in two weeks: sertraline (ZOLOFT); bupropion (WELLBUTRIN). The following information was reported: MIGRAINE (disability) with onset Jul2021, outcome "not recovered", described as "Severe Migraines"; DIZZINESS (disability) with onset Jul2021, outcome "not recovered", described as "Dizziness"; FATIGUE (disability) with onset Jul2021, outcome "not recovered", described as "Fatigue"; NAUSEA (disability) with onset Jul2021, outcome "not recovered", described as "Nausea"; CHILLS (disability) with onset Jul2021, outcome "not recovered", described as "Chills"; HYPERHIDROSIS (disability) with onset Jul2021, outcome "not recovered", described as "Severe Sweating"; DYSPNOEA (disability) with onset Jul2021, outcome "not recovered", described as "Shortness of breath". The events "severe migraines", "dizziness", "fatigue", "nausea", "chills", "severe sweating" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. Adverse event:  Severe Migraines. Dizziness. Fatigue. Nausea. Chills and Severe Sweating. Shortness of breath after normal activities. Has not stopped since Jul2021. Ae resulted in: [Disability or permanent damage]. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was unknown if therapeutic measures were taken as a result of migraine, dizziness, fatigue, nausea, chills, hyperhidrosis, dyspnoea.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Histamine level, Pruritus, Rash
Clinical narrative: Intense, painful itching with a rash which creates anxiety about when the next response is going to happen.  The issue started almost immediately after my booster. three months ago.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Exposure during pregnancy, Fine motor skill dysfunction, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient began having multiple neurological symptoms. Progressive extremity numbness with loss of muscle strength and fine motor skill. Patient is currently 14 weeks pregnant. NIF breathing tests indicate weakness. Diagnosed with GBS. First dose of IVIG given on 2/4.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Muscle strength abnormal, Neurological symptom, Pulmonary function test abnormal
Clinical narrative: Patient began having multiple neurological symptoms. Progressive extremity numbness with loss of muscle strength and fine motor skill. Patient is currently 14 weeks pregnant. NIF breathing tests indicate weakness. Diagnosed with GBS. First dose of IVIG given on 2/4.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Pain in shoulder, deep in joint. Cannot raise my right arm above my head, if I put my hand against my back, cannot move it away from my back.    Treated by pcp, physical therapy, went to orthopedic surgery, believed to be torn rotator cuff.  MRI performed, Only thing shown was inflammation.  Have had 3 injections of steroids.  The radiologist suggested that it might have been my pfizer injection.  I did not think that was it but then looked at how close the pain started after the shot.  I now believe that is it.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.; She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid 19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She said that she got all of her vaccine doses + booster /She said that she recently tested positive with the covid19 virus.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical course: Patient got all the vaccine doses including the booster shot, however, she got tested positive with covid-19. The patient mentioned that she was immunocompromised. Patient wants to know where she can get Paxlovid in (Withheld).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fall, Headache
Clinical narrative: About 1 week after 1st dose started to receive chronic headaches and periods of dizziness to the point of falling over. Once every couple weeks. Muscle and joint soreness. Loss of strength. All of these ailments continue today's date. Has not seen a doctor yet.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: About 1 week after 1st dose started to receive chronic headaches and periods of dizziness to the point of falling over. Once every couple weeks. Muscle and joint soreness. Loss of strength. All of these ailments continue today's date. Has not seen a doctor yet.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Alanine aminotransferase normal, Albumin globulin ratio decreased, Angiogram pulmonary abnormal, Anion gap
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Aspartate aminotransferase normal, Base excess, Basophil count decreased, Basophil percentage decreased
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate increased, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood gases, Blood glucose normal, Blood magnesium normal
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood osmolarity decreased, Blood pH normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, COVID-19, COVID-19 pneumonia, Carbon dioxide normal, Cough
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count, Dyspnoea, Eosinophil count decreased, Eosinophil percentage decreased, Fatigue
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Glomerular filtration rate normal, Haematocrit decreased, Haemoglobin decreased, Lymphocyte count decreased
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Monocyte count decreased, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Oxygen saturation decreased
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: PCO2 normal, PO2 decreased, Platelet count normal, Protein total normal, Red blood cell count decreased
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red cell distribution width normal, SARS-CoV-2 test positive, Troponin I increased, Troponin increased, White blood cell count normal
Clinical narrative: Admitted to hospital 1/31/2022 with Covid-19 pneumonia, acute respiratory failure, elevated troponin. SOB, fatigue, and cough. CTA done to r/o PE, found possible occluded vein graft to RCA. No chest pain. Started on ASA, losartan, metoprolol, discontinued Plavix. Planning nursing home placement on 2/6/2022 which will be 10 days post positive Covid-19 test.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Lymphadenopathy, Oedema, Oedema peripheral
Clinical narrative: Severe edema of left arm and left breast, axillary and subclavicular lymphadenopathy. Left arm pain, left shoulder pain, numbness and tingling in left upper extremity. No significant improvement after 6-day steroid dose pack.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Severe edema of left arm and left breast, axillary and subclavicular lymphadenopathy. Left arm pain, left shoulder pain, numbness and tingling in left upper extremity. No significant improvement after 6-day steroid dose pack.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Polymyalgia rheumatica
Clinical narrative: Patient up until this day was healthy and active until dec25 /2021 patient woke in the morning In severe pai in his shoulders and hip and extremely weak ! Was diagnosed with poly myalgia rumetica
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: GIVEN MODERNA INSTEAD OF PFIZER
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Fever overnight after booster shot given at 4pm, 2/4/22. Awoke at 8:30am 2/5/22 to red rash all over torso, upper left arm, and neck and in ears. Took shower with excema baby soap which helped the itching but now rash is becoming raised and splotchy.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted COVID; contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Feb2021 (Lot number: EL3247) at the age of 43 years as dose 2, single and (Lot number: el3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "recovered" (2022) and all described as "contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive; (14Jan2022) positive; (19Jan2022) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: other vaccine in four weeks. Adverse event contracted COVID. no covid prior vaccination  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pericardial disease, Phlebotomy, Product use issue
Clinical narrative: pericardial tab; Phlebotomy remove iron from body; BNT162b2 and influenza vaccinated on the same day; BNT162b2 and influenza vaccinated on the same day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney replacement" (unspecified if ongoing), notes: transplant years 5 ago; "Liver Biopsy" (unspecified if ongoing); "Eye glasses" (unspecified if ongoing); "immune compromised" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA, administration date 29Nov2021. Vaccination history included: Bnt162b2 (Dose 1), administration date: 07Oct2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: 28Oct2021, for COVID-19 immunization. The following information was reported: PERICARDIAL DISEASE (medically significant), outcome "unknown", described as "pericardial tab"; PHLEBOTOMY (medically significant), outcome "unknown", described as "Phlebotomy remove iron from body"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Nov2021, outcome "unknown" and all described as "BNT162b2 and influenza vaccinated on the same day". Specific relevant test for thromboembolic events with thrombocytopenia was none. Monitor testosterone level kidney. Med diet. 2 family members died of heart disease. Grand parent died of cancer.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101342098 same patient/product, different dose/event
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single and administration date 20Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation at facility. The patient had no relevant medical history. There were no concomitant medications. The patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 03Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (Jan2022) and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Clinical course: The patient did not receive any other vaccine within 4 weeks. The patient did not receive any other medications within 2 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination and resulted positive on 04Jan2022 under quick test (nasal swab test type).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, SARS-CoV-2 test, Shock, Trigeminal neuralgia
Clinical narrative: similar to going into shock; pain in my jaw area; diagnosed with Trigeminal Neuralgia (type 2); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 11:00 (Lot number: EN6205) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Known allergies: Many antibiotics" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient did not receive any vaccines within four weeks prior to the vaccination. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Concomitant medication(s) included: METOPROLOL; AMLODIPINE; XANAX; LOSARTAN; MOTRIN [IBUPROFEN]. Past drug history included: Rphine, reaction(s): "known allergies: rphine".  The following information was reported: SHOCK (disability, medically significant) with onset 07Apr2021, outcome "not recovered", described as "similar to going into shock"; PAIN IN JAW (disability) with onset 07Apr2021, outcome "not recovered", described as "pain in my jaw area"; TRIGEMINAL NEURALGIA (disability) with onset 07Apr2021, outcome "not recovered", described as "diagnosed with Trigeminal Neuralgia (type 2)". Patient began having pain in her jaw area within one month of injection. Reaction to vaccine: similar to going into shock for 4 days. Have been diagnosed with Trigeminal Neuralgia (type 2). Have it ever had any signs of TN prior to vaccination. The events "similar to going into shock", "pain in my jaw area" and "diagnosed with trigeminal neuralgia (type 2)" were evaluated at the physician office visit. Disability or permanent damage. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: Nasal Swab. AE treatment Medication for neuropathy so far. Therapeutic measures were taken as a result of shock, pain in jaw, trigeminal neuralgia.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Vertigo
Clinical narrative: vertigo / spinning really fast; This was the only Pfizer Covid-19 Vaccine she has had, her first 2 doses were Moderna Covid-19 Vaccines.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: 33130BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Moderna covid-19 vaccine (First shot, Lot: 015M20A), for COVID-19 Immunization; Moderna covid-19 vaccine (Second shot, Lot: 098A21A), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Jan2022, outcome "unknown", described as "This was the only Pfizer Covid-19 Vaccine she has had, her first 2 doses were Moderna Covid-19 Vaccines."; IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "Booster"; VERTIGO (non-serious) with onset 20Jan2022 03:00, outcome "not recovered", described as "vertigo / spinning really fast".  Additional information: Caller reported no relevant concomitant products, medical conditions, testing,. treatment or medical interventions relative to this event. She has not required to be seen at Physician's office, emergency room or hospitalization relative to this event. Caller declined to provide contact information for provider, declined consent to contact provider; she had not yet notified provider of this report information. Vertigo: Onset around, another episode at 08:00 and a third episode at 10:30 all on 20Jan2022. Further described as feeling like spinning really fast. Reported as ongoing and persistent, pretty much just stayed the same-documented as provided.  No follow-up attempts were possible. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Osteomyelitis
Clinical narrative: osteomyelitis lumbar spine/Two lesions in lumbar spine; 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 parent.  A male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: 23Mar2021, for Covid-19 immunization. The following information was reported: OSTEOMYELITIS (hospitalization, medically significant) with onset 13Jul2021, outcome "not recovered", described as "osteomyelitis lumbar spine/Two lesions in lumbar spine". The patient was hospitalized for osteomyelitis (start date: 13Jul2021, discharge date: 22Jul2021, hospitalization duration: 9 day(s)). Therapeutic measures were taken as a result of osteomyelitis. He was hospitalized for 9 days beginning 13Jul2021 with osteomyelitis lumbar spine. No risk factors. 6 weeks IV antibiotics completed on 10Sep2021. Hospitalized on 06Oct2021 for another 9 days. Two lesions in lumbar spine. 6 more weeks IV antibiotic with 4 weeks concurrent oral antibiotic. Completed on 10Dec2021. Currently on oral antibiotic until end Feb2022. Drs perplexed a healthy young man has this illness w no risk factors.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 79 with Covid, breathing problems; 79 with Covid, breathing problems; 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 79 year-old patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "79 with Covid, breathing problems". Patient was 79 with Covid, breathing problems, but fighting hard.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Glomerulonephritis membranous
Clinical narrative: acute kidney failure; Membranous nephropathy; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non-smoking" (unspecified if ongoing); "No/non-functioning, spleen or kidney failure: Checked" (unspecified if ongoing); "No/non-functioning, spleen or kidney failure: Checked" (unspecified if ongoing); "exercise and eat healthy" (unspecified if ongoing); "Weakened immune system" (unspecified if ongoing). The patient was a non-smoking, non-alcoholic dealer and exercise and eat healthy. He had no family history of acute immune disease or kidney failure in either parent family history. None prior vaccination (within 4 weeks). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Anatomical site of the injection: left arm, Lot number: EN6208), administration date: 16Mar2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "covid test date=17Aug2021 / covid test result=Positive 17-AUG-2021", "covid test date=17Aug2021 / covid test result=Positive 17-AUG-2021", "Protein urine present", "kidney issues", "edema issues", "high cholesterol", "fatigue"; Bnt162b2 (dose 2, Anatomical site of the injection: left arm, Lot number: EW0161), administration date: 03May2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "covid test date=17Aug2021 / covid test result=Positive 17-AUG-2021", "covid test date=17Aug2021 / covid test result=Positive 17-AUG-2021". The following information was reported: ACUTE KIDNEY INJURY (medically significant) with onset 25Nov2021, outcome "recovering", described as "acute kidney failure"; GLOMERULONEPHRITIS MEMBRANOUS (medically significant) with onset 25Nov2021, outcome "recovering", described as "Membranous nephropathy". The events "acute kidney failure" and "membranous nephropathy" were evaluated at the physician office visit. Therapeutic measures were taken as a result of acute kidney injury, glomerulonephritis membranous, reported as RX drug for kidney failure. Clinical details: Twenty three days after taking vaccine his kidney began to show signs of failure. His kidney failure accelerated over on 25Nov2021. He had water retention, fluid build and protein spilling into urine. He was seeing a nephrologist now and have been diagnosed with acute kidney failure caused by an autoimmune event. Membrane nephropathy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: breakthrough case or not; breakthrough case or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "breakthrough case or not".Reporter was on the phone with someone and was reminded that at some point (Name initials withheld) had Covid, and reporter cannot remember if it was a breakthrough case or not may have been initially told this prior to my time at Pfizer. Regardless, reporter do believe she has recovered and has been back at work for a while. Additionally the case was mild - she did not think she had Covid. Cannot remember exact details but believe case was extremely minor. Reporter believe she is vaccinated, likely with Moderna or Pfizer and at least fully vaccinated, but reporter cannot re-member when this happened. I report this because it may have been a breakthrough case at the time but reporter unsure. She may have also reported side effects at one point, but cannot re-member. Again, reporter may have been told before my time at Pfizer. She is in her 40s I believe.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Loss of efficacy. Contracted asymptomatic Covid-19 post vaccination/Positive covid test result; Loss of efficacy. Contracted asymptomatic Covid-19 post vaccination/Positive covid test result; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 8 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (tris), single and intramuscular, administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. There is no COVID prior vaccination. There is no other vaccine in four weeks, and no Other medications in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "Loss of efficacy. Contracted asymptomatic Covid-19 post vaccination/Positive covid test result". The patient underwent the following laboratory tests and procedures: PCR: (Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: PNC20
Symptoms: Death, Laboratory test normal
Clinical narrative: Pt died one day after receiving Prevnar 20; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), administration date 14Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "had emergency appendectomy" (unspecified if ongoing), notes: 2 weeks prior to receiving a Prevnar 20; "diabetes" (unspecified if ongoing), notes: during the same 2 weeks. The patient's concomitant medications were not reported. The following information was reported: DEATH (death) with onset 15Jan2022, outcome "fatal", described as "Pt died one day after receiving Prevnar 20". Event took place after use of product. The patient underwent the following laboratory tests and procedures: investigation: normal. The patient date of death was 15Jan2022. The reported cause of death was "Pt died one day after receiving Prevnar 20". It was not reported if an autopsy was performed.  The lot number for pneumococcal 20-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: Apart from the plausible temporal relationship, the patient's death is considered unlikely causally associated to PREVNAR 20.  Recent surgical experience of an emergency appendectomy in the patient with underling diabetes may have played a more likely contributory role towards the fata event.  Further information such as complete medical history, concomitant medications, concurrent illness and event term details especially death cause and autopsy results are needed for meaningful evaluation.  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; Reported Cause(s) of Death: Pt died one day after receiving Prevnar 20
Sex: U
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: developed pericarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191).  A patient (no qualifiers provided) of an unspecified age and gender received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown), for Covid-19 immunization.  The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "developed pericarditis". Caller stated that patient took Pfizer COVID-19 vaccine and the booster and developed pericarditis, and was asking if there is a coloration or not. Agent reports caller refused to give any information for name or contact details.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dysphonia, Malaise, SARS-CoV-2 test
Clinical narrative: Hoarse voice; Isn't feeling well; Just getting over covid; Just getting over covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: EN6198) at the age of 74 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, 30 ug single for covid-19 immunisation. Relevant medical history included: "Cancer tumor on the bladder" (unspecified if ongoing), notes: Verbatim: cancer tumor on the bladder; "Cancer tumor on the bladder" (unspecified if ongoing), notes: Verbatim: cancer tumor on the bladder; "It was removed in Dec2021 via surgery", start date: Dec2021 (not ongoing), notes: cancer tumor on the bladder, It was removed in Dec2021 via surgery; "allergic to the vaccine" (unspecified if ongoing), notes: allergic to the vaccine so she was hesitant but she did it anyways. The patient took concomitant medications included antibiotics because the patient just had surgery. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 16Jan2022, outcome "recovering" and all described as "Just getting over covid"; DYSPHONIA (non-serious), outcome "unknown", described as "Hoarse voice"; MALAISE (non-serious), outcome "unknown", described as "Isn't feeling well". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive. It was reported that the patient was taking Pfizer Covid vaccines because she had to travel on an airplane.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: sick with covid/coronavirus for week and half; sick with covid/coronavirus for week and half; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program.  A 62 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: Unknown, Dose number: Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "sick with covid/coronavirus for week and half". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Sick with covid/coronavirus for week and half. The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: Based on the available information a contributory role of BNT162B2 to the reported events COVID-19, Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.