chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, SARS-CoV-2 test
Clinical narrative: Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination.  It is unlikely that thrombocytopenia is related to BNT162B2.  It's more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia noted; Elevated temps to 104; Associated chills; headaches; This is a spontaneous report from a contactable healthcare professional. A 16-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscular on 25Apr2021 (Lot Number: EWO171) as 1st dose, single for covid-19 immunization. Medical history included eczema, Pyle disease, food allergies, short stature, seasonal allergies, peanuts allergies and nuts allergies. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. On 26Apr2021, the patient had elevated temperatures to 104 [unspecified unit], 4-5 days post vaccination (pending clarification) with associated chills and headaches. Thrombocytopenia noted. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was provided for the adverse events. The patient was tested post vaccination with a nasal swab test on 28Apr2021 and the result of negative. The reporter did not consider the events was serious. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event thrombocytopenia was observed only 1 day after vaccination.  It is unlikely that thrombocytopenia is related to BNT162B2.  It's more likely intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cyanopsia, Disorientation, Dizziness, Paraesthesia
Clinical narrative: blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes; lightheaded; tingling feeling from knees to feet; got disoriented; joints aching, knees and arms; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 06Apr2021 08:20 am (Batch/Lot Number: ENB200) as single dose at the age of 75-year-old for COVID-19 immunisation.   The patient medical history and concomitant medications were none. No history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks).  On 06Apr2021, 10 minutes after she received the vaccine, she patient experienced blurred vision, seeing blue and pink flashes in both eyes, she was lightheaded, tingling feeling from knees to feet, got disoriented, joints aching, knees and arms. The events required a visit to Emergency Room. The events were considered medically significant. The outcome of joints aching, knees and arms was recovered on 27Apr2021, of all other events was recovered on 06Apr2021. The course of events was as follows: 10 minutes after she received the vaccine, she experienced blurred vision, seeing a blue and pink flashing in both eyes, she was lightheaded, from her knees down to her feet had a tingling feeling, and she got disoriented. She told her family member something was wrong with her and they got the EMS. The EMS checked her vital signs and suggested to take her to the main campus Emergency Room center. After the knees and arms stopped tingling, different side effects came up on her as she was sitting and waiting for 15 minutes. Patient did not know how long her eyes flashed exactly, but it stopped the same day. Patient had had some differences with her legs, like her joints aching. It lasted from 06Apr2021 to 27Apr2021 until she had to go back for the next vaccine. The joint pain/achiness in legs and arm lasted for 3 weeks on and off. Patient was not hospitalized. No relevant tests performed. Patient has an appointment scheduled with her physician on following Monday. She was scheduled to go back 27Apr2021 for second dose.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vision blurred
Clinical narrative: blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes; lightheaded; tingling feeling from knees to feet; got disoriented; joints aching, knees and arms; This is a spontaneous report from a contactable consumer (patient).  A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 06Apr2021 08:20 am (Batch/Lot Number: ENB200) as single dose at the age of 75-year-old for COVID-19 immunisation.   The patient medical history and concomitant medications were none. No history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks).  On 06Apr2021, 10 minutes after she received the vaccine, she patient experienced blurred vision, seeing blue and pink flashes in both eyes, she was lightheaded, tingling feeling from knees to feet, got disoriented, joints aching, knees and arms. The events required a visit to Emergency Room. The events were considered medically significant. The outcome of joints aching, knees and arms was recovered on 27Apr2021, of all other events was recovered on 06Apr2021. The course of events was as follows: 10 minutes after she received the vaccine, she experienced blurred vision, seeing a blue and pink flashing in both eyes, she was lightheaded, from her knees down to her feet had a tingling feeling, and she got disoriented. She told her family member something was wrong with her and they got the EMS. The EMS checked her vital signs and suggested to take her to the main campus Emergency Room center. After the knees and arms stopped tingling, different side effects came up on her as she was sitting and waiting for 15 minutes. Patient did not know how long her eyes flashed exactly, but it stopped the same day. Patient had had some differences with her legs, like her joints aching. It lasted from 06Apr2021 to 27Apr2021 until she had to go back for the next vaccine. The joint pain/achiness in legs and arm lasted for 3 weeks on and off. Patient was not hospitalized. No relevant tests performed. Patient has an appointment scheduled with her physician on following Monday. She was scheduled to go back 27Apr2021 for second dose.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Peripheral swelling, Rheumatoid arthritis, Thrombosis, Ultrasound scan
Clinical narrative: Blood clot; He was peeing a lot of blood; all of the joints went wondering in one another that was swelling up and it just so painful. Rheumatoid Arthritis layered up; leg swells up twice the size of the other leg; This is a spontaneous report from a contactable consumer reporting for his father.     A male patient of an unspecified age received BNT162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation.  Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced blood clot on an unspecified date with outcome of unknown, he was peeing a lot of blood  on an unspecified date with outcome of unknown, all of the joints went wondering in one another that was swelling up and it just so painful/ he is just swelling up, leg swells up twice the size of the other leg on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ultrasound scan: clot blood. The event thrombosis and hematuria were considered Important Medical Events.  Course of the events: Reporter stated, "My father got the Pfizer Covid vaccine  couple of weeks ago and it caused I think Rheumatoid Arthritis layered up in his joints one of the times started swelling up. He got a blood clot, his legs swelled up like twice the size of the other leg and they did ultrasound on it and got a blood clot. They put him up on blood thinners (Unspecified Medication) now today he had an appointment with the doctor in the room and when he was there he went to the bathroom and then he was peeing a lot of blood. Doctor told him that It should be okay if stop taking the blood thinners and she cleared up and that's it and I am like freaking out that why would they not got him to the hospital. He went to the hospital because it's the other blood clot. People saying this is on the blood thinner. I don't know why is they rolling up a lot. Nobody wants to say its from the vaccine but it is happen in half an hour within the vaccine, its started."  Information about Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia, Paralysis, SARS-CoV-2 test
Clinical narrative: Pins/Needles; Paralysis; Full body weakness; Numbness; This is a spontaneous report from a contactable consumer (patient)   A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 07Apr2021 15:15 as single dose, for covid-19 immunisation. Medical history included Raynaud's phenomenon, cystitis interstitial, motion sickness, allergy to sulfa and macrobid. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced paralysis on 07Apr2021 15:15, full body weakness on 07Apr2021 15:15, numbness on 07Apr2021 15:15, pins/needles  on an unspecified date. The patient was hospitalized for the events for 4 days (start date not reported). No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Apr2021, sars-cov-2 test: negative on 29Apr2021. The events outcome was not recovered.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, Deafness, Dementia, Encephalitis, Gait disturbance
Clinical narrative: Encephalitis; Losing ability to hear; Dementia like symptoms; Loss of Mobility; Urinary incontinence; Having trouble walking; Having trouble talking; This is a spontaneous report from a non-contactable consumer (patient daughter). An unspecified age male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient was in the hospital after getting Encephalitis, which she stated was resulting from the Pfizer COVID vaccine.  The patient also had multiple negative responses from the vaccine.  The reporter would like to know if there was an antidote for the vaccine.  The reporter did not think it was the vaccine that caused this,  but his doctors did.  The patient was also having loss of mobility and tested negative for Coronavirus.  The patient was losing the ability to hear, having urinary incontinence, and was having trouble walking and talking.  Also reports dementia like symptoms that came on after the vaccine. The CDC had already shown up in his hospital room and had been asking questions.  The reporter did not want his private medication information put out there.  The reporter did not wish to create a report and requested to be transferred to have her question answered.  The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Speech disorder, Urinary incontinence
Clinical narrative: Encephalitis; Losing ability to hear; Dementia like symptoms; Loss of Mobility; Urinary incontinence; Having trouble walking; Having trouble talking; This is a spontaneous report from a non-contactable consumer (patient daughter). An unspecified age male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The medical history and concomitant medications were not reported. The patient was in the hospital after getting Encephalitis, which she stated was resulting from the Pfizer COVID vaccine.  The patient also had multiple negative responses from the vaccine.  The reporter would like to know if there was an antidote for the vaccine.  The reporter did not think it was the vaccine that caused this,  but his doctors did.  The patient was also having loss of mobility and tested negative for Coronavirus.  The patient was losing the ability to hear, having urinary incontinence, and was having trouble walking and talking.  Also reports dementia like symptoms that came on after the vaccine. The CDC had already shown up in his hospital room and had been asking questions.  The reporter did not want his private medication information put out there.  The reporter did not wish to create a report and requested to be transferred to have her question answered.  The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, SARS-CoV-2 test
Clinical narrative: increased overall pain; Heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Apr2021 10:00 (Lot Number: EWO153) as 1st dose, single for COVID-19 immunization. The patient's medical history included COVID-19 from unspecified date. Concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient had heart palpitations and increased overall pain which included hospital emergency stay on 07Apr2021 14:00. The events were treated with steroids, pain meds and flexiril. The events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 3 days. The outcome of the events was not recovered. The patient had nasal swab: negative on 27Apr2021 and COVID-19 test: unknown result on unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Nausea, Neck pain, Nephrolithiasis
Clinical narrative: I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation.  The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264).  Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing.   The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.'  Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head.  It is like a crown headache. I have never had problems with headaches before this vaccine.  The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown.   Therapeutic measures were taken as a result of neck pain and headache.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Impaired work ability, Influenza like illness, Neck pain
Clinical narrative: I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient).  A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation.  The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264).  Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing.   The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.'  Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head.  It is like a crown headache. I have never had problems with headaches before this vaccine.  The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown.   Therapeutic measures were taken as a result of neck pain and headache.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two different patients (himself and his wife). This is the first of two reports.  This male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration, in Apr2021 (16 or 17) for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The second dose was planned for 07May2021. The patient asked if he could receive the second dose as he tested positive to COVID-19. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021496701 same reporter/product, different patient / event.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Hives all over her body; Rash all over her body; Pain in arm; This is a spontaneous report from a Pfizer-Sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in deltoid left, on 21Apr2021 (Lot Number: EW0172), as single dose, for COVID-19 immunisation. Medical history was none. No history of allergies or autoimmune disease. Concomitant medications were not reported. The patient experienced hives all over her body (medically significant) on 02May2021 with outcome of not recovered, rash all over her body (medically significant) on 02May2021 with outcome of not recovered, pain in arm (non-serious) on 02May2021 with outcome of unknown.  Therapeutic measures were taken as a result of hives all over her body and rash all over her body and included treatment with antihistamine, Benadryl.   Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Hypertension, Loss of consciousness
Clinical narrative: passed out a total of 3 times; blood pressure went so high; This is a spontaneous report from a contactable consumer reporting for her sister-in-law's sister-in-law. An about 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The reporter stated the patient's blood pressure went so high after she received the COVID-19 Vaccine, that she passed out a total of 3 times. She said she had no clue as to how patient's blood pressure was treated. The reporter thought the 3rd time of passed out from her blood pressure being high, the patient made her husband take her to the Emergency Room. She said adverse reaction occurred around the same time frame as hers, in either Feb2021 or Mar2021. The patient underwent lab tests and procedures which included body height: 5'6" or 5'7". The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Pericardial effusion
Clinical narrative: pericardial effusion tamponade; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN8208) at the age f 66 years old as 2nd dose, single for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Jan2021, (Lot Number: EL9264) in the right arm at the age of 66 for COVID-19 vaccination. The patient reported that she began having signs and symptoms on 29Mar2021; heavy weight in throat like there was a softball in her throat; pressure in that area when she bent over; chest tightness; difficulty breathing; a lot of chest pain; chest stiffness; sharp stabbing pain in upper left chest. The patient stated that it took 13 days and 2 trips to the ER and multiple Doctor calls before they could diagnose what was wrong. She had visited her general doctor who thought she had an embolism and sent her to the Emergency Room on her second visit. They did a D-Dimer test, which they hadn't done on her first Emergency Room visit. The patient was diagnosed with pericardial effusion tamponade on 08Apr2021 as confirmed with the echocardiogram performed on 09Apr2021. On 09Apr2021 they removed the fluid, 700cc of blood, surrounding her heart. The patient was in the ICU from 08Apr2021 to 16Apr2021. The patient stated that she was hoping she would be able to transfer to a hospital but she was in too bad of shape to be transferred. The patient reported that she has some mild symptoms, residual symptoms, some pain in chest and some tightness, but it was much better now. She had an echocardiogram a week after getting out of the hospital which showed no fluid now. The patient was placed on medication. The outcome of the event was recovering.  Follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac tamponade, Computerised tomogram, Echocardiogram, Pericardial effusion
Clinical narrative: pericardial effusion tamponade; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN8208) at the age f 66 years old as 2nd dose, single for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Jan2021, (Lot Number: EL9264) in the right arm at the age of 66 for COVID-19 vaccination. The patient reported that she began having signs and symptoms on 29Mar2021; heavy weight in throat like there was a softball in her throat; pressure in that area when she bent over; chest tightness; difficulty breathing; a lot of chest pain; chest stiffness; sharp stabbing pain in upper left chest. The patient stated that it took 13 days and 2 trips to the ER and multiple Doctor calls before they could diagnose what was wrong. She had visited her general doctor who thought she had an embolism and sent her to the Emergency Room on her second visit. They did a D-Dimer test, which they hadn't done on her first Emergency Room visit. The patient was diagnosed with pericardial effusion tamponade on 08Apr2021 as confirmed with the echocardiogram performed on 09Apr2021. On 09Apr2021 they removed the fluid, 700cc of blood, surrounding her heart. The patient was in the ICU from 08Apr2021 to 16Apr2021. The patient stated that she was hoping she would be able to transfer to a hospital but she was in too bad of shape to be transferred. The patient reported that she has some mild symptoms, residual symptoms, some pain in chest and some tightness, but it was much better now. She had an echocardiogram a week after getting out of the hospital which showed no fluid now. The patient was placed on medication. The outcome of the event was recovering.  Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: Covid test dose that came back positive; covid pneumonia; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the Pfizer covid vaccine on 03Jan2021 and on 04Jan2021, she had a covid test done that came back positive. She went to urgent care and was hospitalized due to covid pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test within the period of waiting for the second dose; positive COVID-19 test within the period of waiting for the second dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no concomitant medications. The patient experienced positive COVID-19 test within the period of waiting for the second dose on an unspecified date. The pharmacist was questioning if they should keep the scheduled date for the second dose or change it. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The clinical outcome of positive COVID-19 test within the period of waiting for the second dose was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Shortly after receiving the first dose, the patient was diagnosed with COVID-19 on unspecified date in 2021. The patient was given plasma on 17Feb2021. The provider recommended getting vaccinated with Johnson and Johnson vaccine. HCP asked if there is any information or recommendations for the patient. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction/Bad reaction; This is a solicited report from a non-contactable consumer.     A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular on an unspecified date (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ibrutinib (IMBRUVICA) taken for an unspecified indication from 22Aug2014, then from an unspecified date and ongoing. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced vaccination adverse reaction/bad reaction to PFIZER VACCINE on an unspecified. The patient was hospitalized for bad reaction for 7 days. Stated he's doing better now and able to move around. The outcome of the event was recovered.   The reporter's causality for the event Vaccination adverse reaction was Possible. The reporter's causality for the event of Bad reaction to PFIZER VACCINE was not provided. The opinion is that there is no reasonable possibility that the event of vaccination adverse reaction/bad reaction to PFIZER VACCINE is related to IMBRUVICA(IBRUTINIB).  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event vaccination complication cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Movement disorder, Parkinson's disease, Speech disorder, Thinking abnormal
Clinical narrative: it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown.  Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts.  Information about lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: it could potentially be his Parkinsons; he started to shake and now is still shaking; he can't concentrate; he doesn't think right; cannot talk right; he has a hard time moving, he moves so slowly; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old (age at time of vaccination) male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 14Apr2021, as a single dose for COVID-19 immunization at clinic. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history included ongoing Parkinson's from 2010. He did not know about family history of having Parkinson's. Concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks prior to vaccination. The patient reported that after two vaccines on an unknown date in Apr2021, he started to shake and now was still shaking. He was wondering why he was shaking so hard. He said it could potentially be his Parkinson's and asked what he should do. Mailing and email address declined. Primary care doctor's address, telephone number, and email address declined. The patient stated the doctor was not in. Shaking was noticed after the second dose. It was improved, but he didn't like it. He could not concentrate, he didn't think right, and could not talk right. When asked to provide information from vaccine card, the patient stated he had a hard time moving, he moved so slowly and had card but could not find it. He also could not recall date of first vaccine, but both doses were given to right arm. Time the vaccination was given: 10:14:2020, was the time that second dose was received. Time was documented as provided, and confirmed, by caller. He had first one and was given another 3 weeks to come back. He was waiting for his doctor and stated he had Parkinson's, diagnosed in 2010. There was no product complaint to report. Outcome of the event he started to shake and now is still shaking was recovering and for all other events, it was unknown.  Communication: Caller had a thick accent- details were as provided by caller with clarifying attempts.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Thrombosis
Clinical narrative: she has a blood clot; had a blood clot and it looked like dark red bruises on the left side of her chest; This is a spontaneous report from a Pfizer sponsored program COVAX US support from a contactable consumer (patient). A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Apr2021. The patient had a blood clot and it looked like dark red bruises on the left side of her chest. She just noticed it after she received her 2nd dose on 27Apr2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I took a PCR Wednesday April 29th and was positive; I took a PCR Wednesday April 29th and was positive; This is spontaneous report received from Pfizer from a contactable consumer (patient). A patient of unknown age and gender received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 and 16Jan2021 seperately, at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received covid vaccine 28Dec2020 and 16Jan2021. The patient had a bad reaction after the second dose but was fine 24 hours later. The patient recently traveled, took a PCR Wednesday 29Apr2021 and was positive. The patient was assuming he/she had a variant strain of the virus, which was unfortunately not able to be covered by the vaccine but just wanted to let you know in case you want a research subject. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, COVID-19, Chills, Drug ineffective, Fatigue
Clinical narrative: Fatigue; Chills; Inflammatory marker increased; Sickness; Uveitis flare up; COVID-19 virus test positive; COVID-19; This is a solicited report based on the information received by Pfizer. A contactable physician reported that a 39 year old female with events of non-serious POSITIVE COVID-19, UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, COLD, BAD COLD, INFLAMMATION MARKERS HIGH and SICK with HUMIRA (ADALIMUMAB). There was no reported medical history.  On unknown dates, the patient experienced UVEITIS FLARE, PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD, INFLAMMATION MARKERS HIGH and SICK. In January 2020, the patient experienced COLD. In January 2020, the COLD resolved. In December 2020, the patient experienced POSITIVE COVID-19. On unknown dates, POSITIVE COVID-19, UVEITIS FLARE and SICK resolved. COVID-19 VACCINE was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events  of POSITIVE COVID-19 and SICK with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of UVEITIS FLARE and COLD with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of PATIENT WAS EXPOSED TO COVID-19 BY BOSS, FATIGUE WAS AWFUL, CHILLS, BAD COLD and INFLAMMATION MARKERS HIGH was not provided.   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.  Information on the batch/lot number requested.; Sender's Comments: As there is no indication of the time interval between the administration of the drug and the onset of events and based on known drug safety profile there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.