chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Fall, Hypoaesthesia, Loss of consciousness
Clinical narrative: passed out and fell; Peripheral Diabetic Neuropathy; upper back pain the radiated from side to side; spasm; numbness in hands and feet; numbness in hands and feet; passed out and fell; dizzy; legs began to tingle; lost my ability to swallow correctly; weak; had no gag reflex and couldn't cough; blow my nose; My legs hurt; had no gag reflex and couldn't cough,; This is a spontaneous report from contactable consumer (Patient herself). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 11:30 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, lupus-like syndrome, atrial, guillain-barre syndrome, food allergy, contrast media allergy from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), metoprolol tartrate (METOPROLOL TARTRATE), fenofibrate (FENOFIBRATE) taken for an unspecified indication. The patient previously took penicilin g, potassium, chantix and experienced hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 11:00 it was reported that, 24 hours after vaccination she started having upper back pain the radiated from side to side. 3 days later she saw PCP who ordered chest x-ray and prescribed muscle relaxer. 4th day pain was worse at night and went to ER, given different medication for spasm. 5th day, pain continued to get worse at night and went to ER had CT of abdomen/Pelvis and given different medication for spasm. 6th day pain worse, returned to ER, had back pain, numbness in hands and feet. Diagnosed with Peripheral Diabetic Neuropathy, given Gabapentin. All this time she had been running on 2 hours a sleep a day. On 10th day, she passed out and fell. On 11th day, she was dizzy and legs began to tingle so went to ER, where she was admitted over the weekend. A CT of Brain and Spine and Doppler were done. Discharged with same diagnosis. Saw Neurologist 6 weeks after onset. During this ordeal on an unspecified dates she lost her ability to swallow correctly and had no gag reflex and couldn't cough, blow her nose. Her legs hurt and she was weak. Diagnosed with GBS. The patient was hospitalized for upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet for 3 days. Therapeutic measures were taken as a result of weak, upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet, peripheral diabetic neuropathy, passed out and fell, passed out and fell, dizzy, legs began to tingle, lost my ability to swallow correctly as patient had received pain medication and physical therapy evaluation. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-up actions are needed. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Paraesthesia, Rhinitis, Ultrasound Doppler
Clinical narrative: passed out and fell; Peripheral Diabetic Neuropathy; upper back pain the radiated from side to side; spasm; numbness in hands and feet; numbness in hands and feet; passed out and fell; dizzy; legs began to tingle; lost my ability to swallow correctly; weak; had no gag reflex and couldn't cough; blow my nose; My legs hurt; had no gag reflex and couldn't cough,; This is a spontaneous report from contactable consumer (Patient herself). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Feb2021 11:30 as single dose for COVID-19 immunization. Medical history included diabetes mellitus, lupus-like syndrome, atrial, guillain-barre syndrome, food allergy, contrast media allergy from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), metoprolol tartrate (METOPROLOL TARTRATE), fenofibrate (FENOFIBRATE) taken for an unspecified indication. The patient previously took penicilin g, potassium, chantix and experienced hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 11:00 it was reported that, 24 hours after vaccination she started having upper back pain the radiated from side to side. 3 days later she saw PCP who ordered chest x-ray and prescribed muscle relaxer. 4th day pain was worse at night and went to ER, given different medication for spasm. 5th day, pain continued to get worse at night and went to ER had CT of abdomen/Pelvis and given different medication for spasm. 6th day pain worse, returned to ER, had back pain, numbness in hands and feet. Diagnosed with Peripheral Diabetic Neuropathy, given Gabapentin. All this time she had been running on 2 hours a sleep a day. On 10th day, she passed out and fell. On 11th day, she was dizzy and legs began to tingle so went to ER, where she was admitted over the weekend. A CT of Brain and Spine and Doppler were done. Discharged with same diagnosis. Saw Neurologist 6 weeks after onset. During this ordeal on an unspecified dates she lost her ability to swallow correctly and had no gag reflex and couldn't cough, blow her nose. Her legs hurt and she was weak. Diagnosed with GBS. The patient was hospitalized for upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet for 3 days. Therapeutic measures were taken as a result of weak, upper back pain the radiated from side to side, spasm, numbness in hands and feet, numbness in hands and feet, peripheral diabetic neuropathy, passed out and fell, passed out and fell, dizzy, legs began to tingle, lost my ability to swallow correctly as patient had received pain medication and physical therapy evaluation. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was not recovered.  Follow-up actions are needed. Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Hypoaesthesia, Lymphadenopathy, Nausea
Clinical narrative: sharp pains; dizziness; swollen lymph nodes in neck; nausea; Numbness down left side of left arm hand foot and leg; burning sensations; pins and needles feelings; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ew0180), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 18:00 (at the age of 38-year-old) as single dose, and dose 2 via an unspecified route of administration, administered in Arm Left on 25Jun2021 18:00 (Batch/Lot Number: Ew0180) (at the age of 38-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Jun2021 18:00, the patient experienced numbness down left side of left arm hand foot and leg, burning sensations, pins and needles feelings, sharp pains, swollen lymph nodes in neck, nausea and dizziness. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: sharp pains; dizziness; swollen lymph nodes in neck; nausea; Numbness down left side of left arm hand foot and leg; burning sensations; pins and needles feelings; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 38-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ew0180), dose 1 via an unspecified route of administration, administered in Arm Left on 04Jun2021 18:00 (at the age of 38-year-old) as single dose, and dose 2 via an unspecified route of administration, administered in Arm Left on 25Jun2021 18:00 (Batch/Lot Number: Ew0180) (at the age of 38-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 04Jun2021 18:00, the patient experienced numbness down left side of left arm hand foot and leg, burning sensations, pins and needles feelings, sharp pains, swollen lymph nodes in neck, nausea and dizziness. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Anxiety, Headache, Heart rate increased
Clinical narrative: Fast heartbeat; Anxiety; Nervousness; Stomach pain; Problems with his eyesight; Like stomach reactions like he is going to vomit but doesn't end up vomiting; Malaise; Headache; Fever; going to vomit but doesn't end up vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's father). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 07Jun2021 (21-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included not reported. The concomitant medications were none. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date on 2021 as dose 1, single for covid-19 immunization. On an unspecified date on 2021, the patient presented symptoms he had never had such as, fast heartbeat, malaise, anxiety, nervousness, headache, stomach pain, problems with his eyesight and fever. The patient had to be admitted into the emergency room, had several studies done and no abnormalities were diagnosed. The reporter stated that Pfizer covid vaccine on 07Jun2021. After the vaccine the patient had a fast heartbeat, general malaise, felt nervous, headache, a stomach-ache, and a fever. The patient had to go to the emergency room, and they performed tests and analysis on him and nothing came up. This event started about a week after the vaccine and his heart rate was speeding up. The heart rate and anxiety and headaches and like stomach reactions like he is going to vomit but doesn't end up vomiting. The symptoms are different on different days. The heart rate only happened once and everything has continued to happen. This happened after the second dose of the vaccine. They sent the patient from the emergency room to another place and admitted him for 2 days. The reporter is unsure of the dates of admission. They sent the patient to a hospital where there was a cardiologist and the patient stayed there for 2 days. As Per fact sheet, what are the risks of the Pfizer BioNTech covid-19 vaccine, revised: 25Jun2021, fast heartbeat is listed as one of the signs of a possible severe allergic reaction. Most of these side effects don´t have a mean duration documented, some of the side effects have a range of appearance from 1-36 days. The reporter asked for treatment recommendations for patient. The events were serious - hospitalization. The outcome for the event's fast heartbeat, visual impairment, abdominal discomfort, pyrexia, going to vomit but doesn't end up vomiting were unknown and other events were not resolved.  Information about batch/lot number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Nervousness, Pyrexia, Visual impairment
Clinical narrative: Fast heartbeat; Anxiety; Nervousness; Stomach pain; Problems with his eyesight; Like stomach reactions like he is going to vomit but doesn't end up vomiting; Malaise; Headache; Fever; going to vomit but doesn't end up vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's father). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 07Jun2021 (21-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. Medical history included not reported. The concomitant medications were none. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date on 2021 as dose 1, single for covid-19 immunization. On an unspecified date on 2021, the patient presented symptoms he had never had such as, fast heartbeat, malaise, anxiety, nervousness, headache, stomach pain, problems with his eyesight and fever. The patient had to be admitted into the emergency room, had several studies done and no abnormalities were diagnosed. The reporter stated that Pfizer covid vaccine on 07Jun2021. After the vaccine the patient had a fast heartbeat, general malaise, felt nervous, headache, a stomach-ache, and a fever. The patient had to go to the emergency room, and they performed tests and analysis on him and nothing came up. This event started about a week after the vaccine and his heart rate was speeding up. The heart rate and anxiety and headaches and like stomach reactions like he is going to vomit but doesn't end up vomiting. The symptoms are different on different days. The heart rate only happened once and everything has continued to happen. This happened after the second dose of the vaccine. They sent the patient from the emergency room to another place and admitted him for 2 days. The reporter is unsure of the dates of admission. They sent the patient to a hospital where there was a cardiologist and the patient stayed there for 2 days. As Per fact sheet, what are the risks of the Pfizer BioNTech covid-19 vaccine, revised: 25Jun2021, fast heartbeat is listed as one of the signs of a possible severe allergic reaction. Most of these side effects don´t have a mean duration documented, some of the side effects have a range of appearance from 1-36 days. The reporter asked for treatment recommendations for patient. The events were serious - hospitalization. The outcome for the event's fast heartbeat, visual impairment, abdominal discomfort, pyrexia, going to vomit but doesn't end up vomiting were unknown and other events were not resolved.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: I have a rear immune deficiency; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated patient was interested in third dose Covid trial. The patient stated, I have a rear immune deficiency on unknown date and have already taken my 2 covid shots. The events assessed as serious (medically significant). The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient mother). A 36-years-old female patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization (Vaccinated at 36 years age). Patient medical history and concomitant medications were not reported. Patient's mother reported that her daughter received the first dose of the Pfizer covid vaccine and had an anaphylactic reaction on an unspecified date in Mar2021 and she was concerned and wanted to know information about her walking around not being fully vaccinated and with the delta variant. She would like to know how protected was her daughter after receiving one dose of the vaccine and to the variant. She wanted to know if there is a pathway for full vaccination with the Pfizer covid vaccine after someone had an anaphylactic reaction to the first dose. She stated under a hospital setting is there a clinical study to support administering a smaller amount. Stated that she talked to (withheld) and thought there would be a study regarding this but she understands that not a lot of people had an anaphylactic reaction to the vaccine. On follow-up on 13Jul2021 she reported that anaphylaxis shock was confirmed by the doctor and she was fine. Patient mother was wondering if there are any other clinical trials. Her daughter was walking around half vaccinated and she was concerned. Patient was taken to a research hospital and they handled the report at hand and verified her adverse event, did not clarified if daughter was actually hospitalized. No further details provided. The outcome for the event was reported as unknown.  Information on lot/batch number has been requested. Further Information was expected.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Joint range of motion decreased, Lung disorder, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; COULD NOT MOVE HANDS OR WRISTS; EFFECTED LUNGS; This is a solicited report based on the information received by Pfizer( MFR Control No. : 21K-163-3982983-00) from a contactable consumer (patient)   A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 subcutaneous on an unspecified date (Batch/Lot number was not reported), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up (rheumatoid arthritis) (medically significant) on an unspecified date with outcome of recovered could not move hands or wrists (non-serious) on an unspecified date with outcome of unknown, "effected lungs" (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: consumer of a 65 year old female with events of non-serious rheumatoid arthritis flare up with covid shot, could not move  hands or wrists and effected lungs with humira (adalimumab). There was no reported medical history. In 2021, the patient experienced rheumatoid arthritis flare up with covid shot, could not move hands or wrists and "effected lungs." On an unknown date, rheumatoid arthritis flare up with covid shot resolved. COVID-19 vaccine was also considered suspect. Reporter's causality for Humira for all event was No Reasonable possibility.  Reporter's causality  for PFIZER BIONTECH COVID-19 VACCINE was not reported for all events   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: The events rheumatoid arthritis flare up and joint range of motion decreased are attributed to the natural course of underlying disease (RA is a relapsing/remitting condition) and is considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information. Event "effected lungs with humira" is considered unrelated to the suspect product and likely represents an intercurrent or underlying disease process. This case will be reassessed upon receipt of additional information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: had a syncopal episode; only symptoms were severe muscle aches and a headache; only symptoms were severe muscle aches and a headache; The entire family had their Pfizer vaccinations in Mar, and all three are positive; The entire family had their Pfizer vaccinations in Mar, and all three are positive.; This is a spontaneous report from the contactable physician. A 68-year-old male patient received both doses (dose 1 and dose 2) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, both doses on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In the last few days, Reporter had four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Patient had a syncopal episode. Patient had only symptoms were severe muscle aches and a headache. The entire family had their Pfizer vaccinations in Mar, and all three are positive on an unknown date in 2021. Patient also appears to have spread it to his wife and adult daughter who are also all fully vaccinated. They had the same symptoms. The patient underwent lab tests and procedure which included SARS-CoV-2 test and was positive on an unknown date in 2021. Outcome of the events was unknown.   Information about batch/lot number has been requested; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: had a syncopal episode; only symptoms were severe muscle aches and a headache; only symptoms were severe muscle aches and a headache; The entire family had their Pfizer vaccinations in Mar, and all three are positive; The entire family had their Pfizer vaccinations in Mar, and all three are positive.; This is a spontaneous report from the contactable physician. A 68-year-old male patient received both doses (dose 1 and dose 2) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, both doses on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In the last few days, Reporter had four new COVID patients after weeks of none. Three of the four were fully vaccinated, all with the Pfizer vaccine. Patient had a syncopal episode. Patient had only symptoms were severe muscle aches and a headache. The entire family had their Pfizer vaccinations in Mar, and all three are positive on an unknown date in 2021. Patient also appears to have spread it to his wife and adult daughter who are also all fully vaccinated. They had the same symptoms. The patient underwent lab tests and procedure which included SARS-CoV-2 test and was positive on an unknown date in 2021. Outcome of the events was unknown.   Information about batch/lot number has been requested; Sender's Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: patient experienced cataract surgery on 28Apr2021; This is a spontaneous report from a contactable consumer. A 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 18Mar2021 as single dose (at the age of 86-years-old) for COVID-19 immunization. Patients medical history included dementia, Patients concomitant medications included lidocaine. It was reported that the patient had cataract surgery on 28Apr2021 but that was the only procedure she has done lately. The patient received her first Pfizer covid vaccine on 18Mar2021 and was concerned that the recall might affect this somehow. The outcome of the event was unknown.  Information on batch/Lot number has been requested.  Follow-up (21Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Spread it to his wife and adult daughter who are also all fully vaccinated; Spread it to his wife and adult daughter who are also all fully vaccinated; This is a spontaneous report from a contactable Physician. This Physician reported for female patient (Wife) of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), dose 1 via an unspecified route on an unknown date, as single dose for COVID-19 immunization and dose 2 via an unspecified route on an unknown date, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced severe muscle aches and a headache. She also appears to have spread it to his wife and adult daughter who are also all fully vaccinated. They had the same symptoms. The entire family had their Pfizer vaccinations in Mar2021, and all three were positive. Vaccine efficacy was determined in the original trials against symptomatic COVID disease at a time when prevention of severe pneumonia was the goal-but we really do not know for Moderna and Pfizer what is VE against atypical/asymptomatic infection. Please let us know if these patients get sicker or have mild disease. We have seen several patients also who have been vaccinated and are coming back with positive tests. Many of them have not been ill and had high cycle threshold which may reflect asymptomatic infection. We did have two immunocompromised hosts with severe infection and poor outcome. Since 01Feb2021 (somewhat arbitrary date when COVID vaccination was widely available in the community), 95% of our COVID admissions have been in individuals who were either unvaccinated or not fully vaccinated. Of those fully vaccinated patients who tested positive, nearly 50% were asymptomatic and tested positive for preprocedural screening or screening for placement in a congregate living facility. We have found fully vaccinated patients who are taking rituximab seem particularly vulnerable to break through infections, but otherwise the vaccine has been quite effective. (withheld) was hit particularly hard with Alpha variant surge this spring with high rates of COVID hospitalizations from mid-March to mid-June. Over the past month, COVID rates have remained low without any particular surprising break through cases.  Information on Lot/Batch information has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and the suspect drug BNT162B2..
Sex: U
Vaccine: FLUX
Symptoms: Acute haemorrhagic leukoencephalitis, Cerebral haemorrhage, Magnetic resonance imaging head abnormal, Plasmapheresis, Vasogenic cerebral oedema
Clinical narrative: acute hemorrhagic leukoencephalitis; vasogenic edema including involvement of the pons; significant areas of hemorrhage; Initial information was received on 20-Jul-2021 regarding an unsolicited valid serious case from other healthcare professional issued from a literature article.   This case involves an adult patient (gender unknown) who had acute hemorrhagic leukoencephalitis (acute haemorrhagic leukoencephalitis) with the symptom vasogenic edema including involvement of the pons (vasogenic cerebral oedema) and significant areas of hemorrhage (Cerebral hemorrhage ) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), and family history were not provided.  Information on concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious acute hemorrhagic leukoencephalitis (acute haemorrhagic leukoencephalitis) with the symptoms vasogenic edema including involvement of the pons (vasogenic cerebral oedema) and significant areas of hemorrhage (Cerebral hemorrhage ) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  Relevant laboratory test results included: Magnetic resonance imaging - On an unknown date: showed significant areas of hemorrhage with vasogenic edema including involvement of the pons.  The patient was aggressively treated with plasma exchange and corticosteroids (unspecified) for the events and had a favorable outcome.  At, the time of reporting the final outcome of the events was unknown.; Sender's Comments: This case concerns a an adult patient (unknown gender) who had acute haemorrhagic leukoencephalitis with the symptom vasogenic cerebral oedema and cerebral hemorrhage  after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's laboratory test included Magnetic resonance imaging (MRI) (brain) that showed significant areas of hemorrhage with vasogenic edema including involvement of the pons. Additional information regarding medical history, condition at the time of vaccination and other lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Headache, Pyrexia
Clinical narrative: After vaccine I had headache, fever and arthalgia
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemoglobin decreased, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenic purpura, Ultrasound Doppler normal, White blood cell count increased
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acid base balance, Blood test, Contusion, Full blood count, Haematocrit
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Immunoglobulin therapy, Lymphocyte count, Metabolic function test
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet count, Platelet count decreased, Platelet factor 4, SARS-CoV-2 test
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenic purpura, Ultrasound Doppler, Ultrasound Doppler normal, Ultrasound scan, White blood cell count
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves  Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Lip swelling
Clinical narrative: Swallowing of lips and rush in the face aftee second dosis of Pfizee vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had it /  even with vaccinations / does not "prevent"/Suspected Vaccination failure; I've had it 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported The reporter said this was false advertising.  Vaccine does not prevent shingles, but perhaps it could possibly lessen the reaction when getting shingles.  The patient stated that you could get shingles over and over.  The patient had it 3 times even with vaccinations. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details provided for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingle shot (2) in 2019 and now / shingles/ suspected vaccination failure; shingles on right side of back; under right breast; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 81-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient received 2 doses of Shingles shot and experienced shingles on right side of his/her back and under the right breast. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the 1st / shot over 11 months ago / need to start over since it's been longer than 6 months?; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date 11 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself/himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient not yet receive second dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient asked need to start over since it has been longer than 6 months
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: if the 2nd dose is given 8 months after the first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date 8 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient enquired if the vaccine would still be effective if second dose received after 6 months.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019. /would like their second dose; This case was reported by a other health professional via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The health care professional enquired if they could administer 2nd dose or needed to restart the series.