chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet transfusion
Clinical narrative: In June 2021, platelet count was roughly 360,000. Was given Covid vaccine in August and second dose in September of 2021. Having spells of fatigue, lightheadedness and shortness of breath. Discovered in November of 2021 by primary care doctor that platelet count was roughly 50,000. Primary care was monitoring platelets. They were fluctuating up and down, never getting above 100,000. Primary care recommended seeing a Hematologist in late December. Late December, Hematology put me on high dose of prednisone to try to counteract platelet levels. Platelet levels were not doing anything so we began slowly tapering off the steroid. During that time, January 8, 2022, I became very lethargic, very fatigue and had severe headache. That night, my mother took me to the ER and my platelet count was critical (7,000). I received 2 bags of platelet infusions at hospital and mom transported me to another hospital. Once at hospital, platelet count was 17,000. Received 1st IVIG treatment in the ER and was admitted. 2nd dose of IVIG treatment was given once a room became available the following night. Later discharged the next day. After IVIG treatments, platelet count was over 500,000.   I was admitted again late January 2022, platelets got low not critical. I had a bone marrow biopsy later on and showed I have Chronic ITP. During this time, I was given 4 rounds of Rituximab Infusions and my platelets have been under 120,000 since.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving Gardasil 9, Menactra, and Bexsero vaccines in clinic.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, C-reactive protein increased, Chills, Dehydration, Electrocardiogram abnormal
Clinical narrative: Had Moderna booster at noon and by 7:00 p.m. I had extreme body aches, chills. Next morning high temp and worst headache, worst body aches, or sore throat that I've ever had. Dehydrated so received fluids and pain meds from urgent care. Same thing on Sunday but MD decided to run labs. Troponin 281, d-dimer 3.93, abnormal EKG, C-reactive protein 99.6, ESR 56, low rbc, hematocrit, hemoglobin, platelets. Ambulance to hospital. Diagnosed with double pneumonia, IV antibiotics for 3 days 02 in the 70s lots of wheezing.
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Haematocrit, Haemoglobin, Headache, Oropharyngeal pain
Clinical narrative: Had Moderna booster at noon and by 7:00 p.m. I had extreme body aches, chills. Next morning high temp and worst headache, worst body aches, or sore throat that I've ever had. Dehydrated so received fluids and pain meds from urgent care. Same thing on Sunday but MD decided to run labs. Troponin 281, d-dimer 3.93, abnormal EKG, C-reactive protein 99.6, ESR 56, low rbc, hematocrit, hemoglobin, platelets. Ambulance to hospital. Diagnosed with double pneumonia, IV antibiotics for 3 days 02 in the 70s lots of wheezing.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Platelet count, Pneumonia, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: Had Moderna booster at noon and by 7:00 p.m. I had extreme body aches, chills. Next morning high temp and worst headache, worst body aches, or sore throat that I've ever had. Dehydrated so received fluids and pain meds from urgent care. Same thing on Sunday but MD decided to run labs. Troponin 281, d-dimer 3.93, abnormal EKG, C-reactive protein 99.6, ESR 56, low rbc, hematocrit, hemoglobin, platelets. Ambulance to hospital. Diagnosed with double pneumonia, IV antibiotics for 3 days 02 in the 70s lots of wheezing.
Sex: F
Vaccine: COVID19
Symptoms: Troponin, Wheezing
Clinical narrative: Had Moderna booster at noon and by 7:00 p.m. I had extreme body aches, chills. Next morning high temp and worst headache, worst body aches, or sore throat that I've ever had. Dehydrated so received fluids and pain meds from urgent care. Same thing on Sunday but MD decided to run labs. Troponin 281, d-dimer 3.93, abnormal EKG, C-reactive protein 99.6, ESR 56, low rbc, hematocrit, hemoglobin, platelets. Ambulance to hospital. Diagnosed with double pneumonia, IV antibiotics for 3 days 02 in the 70s lots of wheezing.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: I am getting dozy for a few weeks. I wonder if it could be Covid vaccine? A lady friend has the same symptoms. We both 75 but I smoke and drink. She does no smoke or drink. Mine cardiologist regular check ups are clear. The lady's are also clear.. I have been taken my medicines (listed below) for many years. I've been under doctor's care for over 35 years. I have not complaint of this situation to my doctor, However sporadic blood pressure checks are always around 120-130/70-80. I fear is the covid vaccine side effect.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error, Syringe issue
Clinical narrative: COVID-19 Vaccine, MRNA, (Pfizer) Mcg/0.3 Ml IM Susp (purple) use for COVID-19 under Emergency Use Authorization (EUA): Pfizer Covid Vaccine was prepared at 10:42 and delivered around 11:00 to 5W. It was unknown to who delivered this medication. I spoke with the pharmacist, all employees in bullpen at the time and all deny delivering this med. A yellow sheet was prepared to document delivery, but this yellow sheet was not returned to pharmacy to show who delivered it. The syringe was dispensed in a brown light protect bag. After 15:00, RN messaged for medication saying that the syringe they had was completely depressed and not medication was in syringe. Medication would have been expired by this time as these doses need to be used within an hour of drawing up. We prepared a new dose and technician retrieved old dose. The old dose had been completely depressed and dose expelled into syringe cap. Additionally, syringe had been repackaged from it's light protect bag into a refrigerator bag and placed back in pyxis. We are not sure who depressed the plunger or repackaged the syringe into a different bag. All employees deny delivering this medication. I asked if anyone placed this syringe in the stat bin on operations side to be delivered and they denied this as well. We attempted to call orange AM tech to see if it wan accidentally placed on delivery, but we were not able to reach them. Overall this was very bizarre situation and we're not sure what happened to the yellow delivery sheet which would offer some clarity.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Covid-19 Vacc Mrna (5-11yr) (Pfizer) 10Mcg/0.2 Ml IM Susp (orange) use for COVID-19 under Emergency Use Authorization (EUA): Covid Vaccine was not diluted properly resulting in wrong dose of vaccine given to patient.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: [Covid-19 Vacc Mrna (5-11yr)(pfizer)(pf) 10 Mcg/0.2 Ml Im Susp (orange)] use for COVID-19 under Emergency Use Authorization (EUA): Covid vaccine was not diluted properly resulting in wrong dose of vaccine given to patient.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: [Moderna] use for COVID-19 under Emergency Use Authorization (EUA):Covid-19 Vacc Mrna (5-11yr)(pfizer)(pf) 10 Mcg/0.2 Ml Im susp (orange.) Covid vaccine was not diluted properly resulting in wrong dose of vaccine given to patient.
Sex: U
Vaccine: RAB
Symptoms: Wrong technique in product usage process
Clinical narrative: RN failed to reconstitute vaccine and administered IM injection without contents of vaccine. Patient called and notified, patient planning to come back to ED for vaccine on 06/21/22.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: I gave Hepatitis A after a second check but did not chart it until after immunization was given. It expired 04/2022.
Sex: U
Vaccine: PPV
Symptoms: Transcription medication error
Clinical narrative: Scrubbing chart for clinic visit. noting pt with 2 entries for pneumococcal vaccine, both with same lot number and Merck as company, one with generic pneumococcal vaccine and other with Pneumococcal-7. Pt is 42 y/o and these were documented in 2013. Merck does not make Pneumococcal 7.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: COVID-19 Vacc MRNA (5-11yr) (Pfizer) 10 Mcg/0.2 Ml Im Susp (Orange) use for COVID-19 under Emergency Use Authorization (EUA) : Covid vaccine was not diluted properly resulting in wrong dose of vaccine gibe to patient
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: after 2 vaccinations and 2 boosters (Moderna) (4/4/22 forth shot) I self tested positive for COVID on May 26. I received a Monoclonal Infusion 2 days later. I now feel fine.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired vaccine to 5 patients; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 22nd May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-Jun-2022. Reporter's Comments: The pharmacist reported that a clinic inadvertently administered expired Shingrix vaccine to the patient. The HCP (Health Care Professional) had no information at time of chat for lot number or patient details but told she could get it might follow up via email or telephone. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently received expired Shingrix vaccine, which led to expired vaccine used. This was 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100398:Same case/same reporter US-GLAXOSMITHKLINE-US2022099891:Same case/same reporter US-GLAXOSMITHKLINE-US2022099891:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100400:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100398:Same case/same reporter
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 27Feb2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022 at 12:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 26Jun2022, treatment stop date was 30Jun2022 and indication was treatment of COVID-19. Positive test 5 days after finishing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: he now has corona; he now has corona; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW0167), in right arm and on 21May2021 as dose 2, single (Lot number: EW0168), in right arm for COVID-19 immunization. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: he has COPD; "he was in a head on car accident and his guts were leaking and they discharged him after 4 days", start date: 2008 (unspecified if ongoing); "he was still sick" (ongoing). The patient's 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 "he now has corona".  Additional information: The patient stated he was almost 59 years old in another month and they almost killed him back in 2008. The patient further stated he was in a head on car accident and his guts were leaking and they discharged him after 4 days and he knew he was still sick and his friend (name withheld) took him back to the hospital and he woke up 6 days later with a colostomy bag and guts sutured.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 64 year old female. Initial information was processed along with additional information was received on 05-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: ehlers danlos syndrome, and drug allergy (Levequine). The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 15-MAR-2021 13:30 to left arm for prophylactic vaccination. Age at time of vaccination 62 years old. The batch number was not reported and has been requested. Concomitant medications included Armour Tyroid (thyroid) for drug use for unknown condition. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 22-JUN-2022 and last dose on 22-JUN-2022 for covid-19 treatment. On 22-JUN-2022 at 19:00, within four hours of taking Paxlovid, she experienced muscle pain throughout her body. She could barely move as the pain was so severe. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000241005.; Sender's Comments: V0: 20220706726-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac normal, Pulseless electrical activity, Ventricular fibrillation
Clinical narrative: On 1/9/2022, I was driving home from work and went into V-Fib and blacked out, which resulted in auto accident. CPR was started at site. Was hospitalized for 5 days, with 4 days in ICU and in coma.  Released 1/14/2022 with holter monitor for heart.  2/14/22, stood up in living room and blacked out again, hit large coffee table when I fell, hitting nose, head and ribs. Husband found me on floor covered in blood, and was not breathing.  He tried CPR, and called EMS. Was taken to hospital again, diagnosed with V-Fib  and AICD was implanted 2/16/22.  Released on 2/17/22, and on 2/23/22 while on reclining chair blacked out again, and AICD shocked me back into rhythm.  Was admitted to hospital again. Was started on Amiodarone (RX)  This medication has serious side effects, so have to be monitored.  These episodes have caused severe panic and anxiety, and now I take an anti-depressant.  With my most recent heart ultra sound, they have determined that my ejection fraction is slightly low. After my last blood test, they are having to watch my kidney functions because numbers were high. None of these conditions had been diagnosed, prior to the first V-fib on 1/9/22.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test abnormal, Chest injury, Coma, Echocardiogram abnormal
Clinical narrative: On 1/9/2022, I was driving home from work and went into V-Fib and blacked out, which resulted in auto accident. CPR was started at site. Was hospitalized for 5 days, with 4 days in ICU and in coma.  Released 1/14/2022 with holter monitor for heart.  2/14/22, stood up in living room and blacked out again, hit large coffee table when I fell, hitting nose, head and ribs. Husband found me on floor covered in blood, and was not breathing.  He tried CPR, and called EMS. Was taken to hospital again, diagnosed with V-Fib  and AICD was implanted 2/16/22.  Released on 2/17/22, and on 2/23/22 while on reclining chair blacked out again, and AICD shocked me back into rhythm.  Was admitted to hospital again. Was started on Amiodarone (RX)  This medication has serious side effects, so have to be monitored.  These episodes have caused severe panic and anxiety, and now I take an anti-depressant.  With my most recent heart ultra sound, they have determined that my ejection fraction is slightly low. After my last blood test, they are having to watch my kidney functions because numbers were high. None of these conditions had been diagnosed, prior to the first V-fib on 1/9/22.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram ambulatory abnormal, Fall, Haemorrhage, Head injury
Clinical narrative: On 1/9/2022, I was driving home from work and went into V-Fib and blacked out, which resulted in auto accident. CPR was started at site. Was hospitalized for 5 days, with 4 days in ICU and in coma.  Released 1/14/2022 with holter monitor for heart.  2/14/22, stood up in living room and blacked out again, hit large coffee table when I fell, hitting nose, head and ribs. Husband found me on floor covered in blood, and was not breathing.  He tried CPR, and called EMS. Was taken to hospital again, diagnosed with V-Fib  and AICD was implanted 2/16/22.  Released on 2/17/22, and on 2/23/22 while on reclining chair blacked out again, and AICD shocked me back into rhythm.  Was admitted to hospital again. Was started on Amiodarone (RX)  This medication has serious side effects, so have to be monitored.  These episodes have caused severe panic and anxiety, and now I take an anti-depressant.  With my most recent heart ultra sound, they have determined that my ejection fraction is slightly low. After my last blood test, they are having to watch my kidney functions because numbers were high. None of these conditions had been diagnosed, prior to the first V-fib on 1/9/22.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Implantable defibrillator insertion, Intensive care, Loss of consciousness, Nasal injury, Panic attack
Clinical narrative: On 1/9/2022, I was driving home from work and went into V-Fib and blacked out, which resulted in auto accident. CPR was started at site. Was hospitalized for 5 days, with 4 days in ICU and in coma.  Released 1/14/2022 with holter monitor for heart.  2/14/22, stood up in living room and blacked out again, hit large coffee table when I fell, hitting nose, head and ribs. Husband found me on floor covered in blood, and was not breathing.  He tried CPR, and called EMS. Was taken to hospital again, diagnosed with V-Fib  and AICD was implanted 2/16/22.  Released on 2/17/22, and on 2/23/22 while on reclining chair blacked out again, and AICD shocked me back into rhythm.  Was admitted to hospital again. Was started on Amiodarone (RX)  This medication has serious side effects, so have to be monitored.  These episodes have caused severe panic and anxiety, and now I take an anti-depressant.  With my most recent heart ultra sound, they have determined that my ejection fraction is slightly low. After my last blood test, they are having to watch my kidney functions because numbers were high. None of these conditions had been diagnosed, prior to the first V-fib on 1/9/22.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal function test abnormal, Respiratory arrest, Resuscitation, Road traffic accident, Ventricular fibrillation
Clinical narrative: On 1/9/2022, I was driving home from work and went into V-Fib and blacked out, which resulted in auto accident. CPR was started at site. Was hospitalized for 5 days, with 4 days in ICU and in coma.  Released 1/14/2022 with holter monitor for heart.  2/14/22, stood up in living room and blacked out again, hit large coffee table when I fell, hitting nose, head and ribs. Husband found me on floor covered in blood, and was not breathing.  He tried CPR, and called EMS. Was taken to hospital again, diagnosed with V-Fib  and AICD was implanted 2/16/22.  Released on 2/17/22, and on 2/23/22 while on reclining chair blacked out again, and AICD shocked me back into rhythm.  Was admitted to hospital again. Was started on Amiodarone (RX)  This medication has serious side effects, so have to be monitored.  These episodes have caused severe panic and anxiety, and now I take an anti-depressant.  With my most recent heart ultra sound, they have determined that my ejection fraction is slightly low. After my last blood test, they are having to watch my kidney functions because numbers were high. None of these conditions had been diagnosed, prior to the first V-fib on 1/9/22.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Injected limb mobility decreased, Oedema peripheral, Pain, Swelling
Clinical narrative: a change in my bowels; diarrhea worse than ever before; diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms; caloprotectin level and it was 1280; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included none. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 01, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis"; Moderna covid-19 vaccine (Dose: 02, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis".  The following information was reported: FUNCTIONAL GASTROINTESTINAL DISORDER (non-serious) with onset 12Jun2022, outcome "unknown", described as "a change in my bowels"; FAECAL CALPROTECTIN INCREASED (medically significant) with onset 2022, outcome "unknown", described as "caloprotectin level and it was 1280"; COLITIS ULCERATIVE (medically significant) with onset 2022, outcome "unknown", described as "diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea worse than ever before". The patient underwent the following laboratory tests and procedures: Stool analysis (0-50): (unspecified date) 1280, notes: My doctor did a stool study to check for inflammation, caloprotectin level and it was 1280; (Mar2022) 55, notes: My level in March was 55. Normal is 0-50.  Clinical course: Patient filed a vaers report for patient's Pfizer booster received on 27Apr2022. Patient updated it today because around 12Jun2022 patient started to have a change in my bowels. Patient had already diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer patient had worsening in symptoms and diarrhea worse than ever before.Patient's doctor did a stool study to check for inflammation, caloprotectin level and it was 1280. Patient's level in Mar2022 was 55. Normal range was 0-50.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tenderness
Clinical narrative: a change in my bowels; diarrhea worse than ever before; diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms; caloprotectin level and it was 1280; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included none. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 01, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis"; Moderna covid-19 vaccine (Dose: 02, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis".  The following information was reported: FUNCTIONAL GASTROINTESTINAL DISORDER (non-serious) with onset 12Jun2022, outcome "unknown", described as "a change in my bowels"; FAECAL CALPROTECTIN INCREASED (medically significant) with onset 2022, outcome "unknown", described as "caloprotectin level and it was 1280"; COLITIS ULCERATIVE (medically significant) with onset 2022, outcome "unknown", described as "diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea worse than ever before". The patient underwent the following laboratory tests and procedures: Stool analysis (0-50): (unspecified date) 1280, notes: My doctor did a stool study to check for inflammation, caloprotectin level and it was 1280; (Mar2022) 55, notes: My level in March was 55. Normal is 0-50.  Clinical course: Patient filed a vaers report for patient's Pfizer booster received on 27Apr2022. Patient updated it today because around 12Jun2022 patient started to have a change in my bowels. Patient had already diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer patient had worsening in symptoms and diarrhea worse than ever before.Patient's doctor did a stool study to check for inflammation, caloprotectin level and it was 1280. Patient's level in Mar2022 was 55. Normal range was 0-50.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Faecal calprotectin increased, Functional gastrointestinal disorder, Stool analysis
Clinical narrative: a change in my bowels; diarrhea worse than ever before; diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms; caloprotectin level and it was 1280; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included none. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose: 01, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis"; Moderna covid-19 vaccine (Dose: 02, I had already been diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021.), administration date: 2021, for Covid-19 immunization, reaction(s): "ulcerative proctitis colitis".  The following information was reported: FUNCTIONAL GASTROINTESTINAL DISORDER (non-serious) with onset 12Jun2022, outcome "unknown", described as "a change in my bowels"; FAECAL CALPROTECTIN INCREASED (medically significant) with onset 2022, outcome "unknown", described as "caloprotectin level and it was 1280"; COLITIS ULCERATIVE (medically significant) with onset 2022, outcome "unknown", described as "diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer I had worsening in symptoms"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "diarrhea worse than ever before". The patient underwent the following laboratory tests and procedures: Stool analysis (0-50): (unspecified date) 1280, notes: My doctor did a stool study to check for inflammation, caloprotectin level and it was 1280; (Mar2022) 55, notes: My level in March was 55. Normal is 0-50.  Clinical course: Patient filed a vaers report for patient's Pfizer booster received on 27Apr2022. Patient updated it today because around 12Jun2022 patient started to have a change in my bowels. Patient had already diagnosed with ulcerative proctitis colitis after the first 2 Moderna shots in 2021. But now after Pfizer patient had worsening in symptoms and diarrhea worse than ever before.Patient's doctor did a stool study to check for inflammation, caloprotectin level and it was 1280. Patient's level in Mar2022 was 55. Normal range was 0-50.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dry throat, Fatigue, Feeling abnormal, Night sweats
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/REBOUNDED; This spontaneous report received from a patient concerned a 51 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination and experienced suspected clinical vaccination failure (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. Patient received 2nd dose of non-company suspect vaccine: elasomeran (dose number in series 2) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with 2nd dose of moderna.(dose number in series 2). Patient received 3rd dose of non-company suspect vaccine: elasomeran (dose number in series 3) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose was not reported, administered on 25-APR-2022 at 12:00 pm to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced suspected covid-19 infection and rebounded (dose number in series 3).  Patient received other company co-suspect Paxlovid (form of admin, route of admin and batch number were not reported), administered from 4-JUN-2022 to 9-JUN-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable. The outcome of the suspected covid-19 infection/rebounded and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0: 20220706981-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/REBOUNDED; This spontaneous report received from a patient concerned a 51 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination and experienced suspected clinical vaccination failure (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. Patient received 2nd dose of non-company suspect vaccine: elasomeran (dose number in series 2) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with 2nd dose of moderna.(dose number in series 2). Patient received 3rd dose of non-company suspect vaccine: elasomeran (dose number in series 3) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose was not reported, administered on 25-APR-2022 at 12:00 pm to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced suspected covid-19 infection and rebounded (dose number in series 3).  Patient received other company co-suspect Paxlovid (form of admin, route of admin and batch number were not reported), administered from 4-JUN-2022 to 9-JUN-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable. The outcome of the suspected covid-19 infection/rebounded and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0: 20220706981-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/REBOUNDED; This spontaneous report received from a patient concerned a 51 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination and experienced suspected clinical vaccination failure (dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. Patient received 2nd dose of non-company suspect vaccine: elasomeran (dose number in series 2) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with 2nd dose of moderna.(dose number in series 2). Patient received 3rd dose of non-company suspect vaccine: elasomeran (dose number in series 3) (moderna covid-19 vaccine)(form of admin, route of admin, and batch number were not reported), dose was not reported, administered on 25-APR-2022 at 12:00 pm to the left arm for prophylactic vaccination. On an unspecified date, the patient experienced suspected covid-19 infection and rebounded (dose number in series 3).  Patient received other company co-suspect Paxlovid (form of admin, route of admin and batch number were not reported), administered from 4-JUN-2022 to 9-JUN-2022 for covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable. The outcome of the suspected covid-19 infection/rebounded and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0: 20220706981-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Malaise, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "known allergies Coconut" (unspecified if ongoing), notes: known allergies Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Plaxovid, from 22Jun2022 to 26Jun2022.   Clinical Information: The patient received other medications within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "known allergies Coconut" (unspecified if ongoing), notes: known allergies Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Plaxovid, from 22Jun2022 to 26Jun2022.   Clinical Information: The patient received other medications within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "known allergies Coconut" (unspecified if ongoing), notes: known allergies Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Plaxovid, from 22Jun2022 to 26Jun2022.   Clinical Information: The patient received other medications within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Malaise, Pyrexia, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11May2022 at 18:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "known allergies Coconut" (unspecified if ongoing), notes: known allergies Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Plaxovid, from 22Jun2022 to 26Jun2022.   Clinical Information: The patient received other medications within 2 weeks of starting COVID-19 treatment. The patient previously received COVID-19 Vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication; Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 04Jan2021 as dose 2, single (Lot number: EK3730), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication". The adverse event resulted in none. Paxlovid Covid-19 treatment Oral (Lot number: 6C9431) received from 25Jun2022 to 29Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure, covid-19..
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication; Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 04Jan2021 as dose 2, single (Lot number: EK3730), in left arm and on 01Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound symptoms. Restarted with nasal stuffiness and some coughing 6 days after completing the medication". The adverse event resulted in none. Paxlovid Covid-19 treatment Oral (Lot number: 6C9431) received from 25Jun2022 to 29Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure, covid-19..