chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Drug eruption, Hypersensitivity, Lyme disease, Peripheral swelling, Rash
Clinical narrative: urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering.  Follow up needed, further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin test, Sleep disorder, Urticaria, Vaccination site mass
Clinical narrative: urticaria (hives) or drug eruption; urticaria (hives) or drug eruption; disrupting sleep; allergic reaction to COVID vaccine; Severely swollen left hand; rash bounced between hands and feet/ Rash kept moving randomly around all over body; Itchy rash inner left arm/ itchy rashes on left palm; Lump on left arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 13Apr2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 19Mar2021 at age of 60-year-old as single dose for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. On 15Apr2021 (Day 2), patient had lump on left arm at injection site. On 16Apr2021 (Day 3), itchy rash inner left arm. On 17Apr2021 (Day 4), itchy rashes on left palm. Over next few days rash bounced between hands and feet. On 21Apr2021 (Day 8), patient went to clinic for severely swollen left hand. They almost cut off wedding ring. Tested for Limes Disease. Next major swelling and rash traded between Rt hand, Left foot, Rt foot. At one point left fingertips felt burnt. On 29Apr2021 (Day 16), family doctor told the patient Lyme disease test was negative. Doctor suggested he was having allergic reaction to COVID vaccine. Rash kept moving randomly around all over body, disrupting sleep. Took antihistamines Benadryl, Loratadine and used steroid cream. On 04May2021 (Day 21), dermatologist took skin sample from rash to test. Rash continued. On 19May2021 (Day 36), dermatologist said test suggests urticaria (hives) or drug eruption. Told me to take 4 Loratadine, 2 Benadryl, 1 Pepcid. Rash almost totally disappeared (4 days ago). Supposed to continue regimen for two months. The adverse event resulted in Doctor or other healthcare professional office/ clinic visit, emergency room/ department or urgent care. The outcome of events was recovering.  Follow up needed, further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA, minor just one day only lasting stroke; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had an adverse reaction to the vaccine within a couple of days. TIA, minor just one day only lasting stroke. If symptoms are only within 24 hours its not a stroke its a TIA. Outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain, Pyrexia
Clinical narrative: Heart rate is going quite up around 140; Having body ache; Fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20May2021 (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. In May2021, the patient was having body ache, fever and her heart rate is also going quite up around 140, so the reporter just wanted to check recommendation and asked if it was okay for her to take Tylenol with the vaccine? also added, "Are there any medications that are not supposed to be taken like Ibuprofen, Tylenol, paracetamol or something which she can take for her fever and body ache?" The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: Heart problems; Diagnosed him with pericarditis that's the inflammation of the heart; This is a spontaneous report from a contactable consumer. A 17-year-old male patient (reporter's brother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0153), via an unspecified route of administration on an unspecified date (at 17-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was reported as none and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number unknown), via an unspecified route of administration on an unspecified date (at an unspecified age) as 1st dose, single for COVID-19 immunisation. On an unspecified date after the second dose of vaccine, the patient had heart problem and doctor diagnosed him with pericarditis that's the inflammation of the heart. Lab test: He went under test after he had the symptoms multiple EKGs, multiple blood test, CT scan, and he also did ultrasound for his heart. Treatment: For the side effects he took some Motrin, for the heart problems the cardiologist told him to take some Motrin, it's Ibuprofen and that's for the side effects. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pyrexia
Clinical narrative: High fever that resulted in loss of pregnancy; High fever; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration on 08Apr2021 12:00 (at the age of 35-year-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. No other medications the patient received within 2 weeks of vaccination. On an unspecified date, the patient experienced high fever that resulted in loss of pregnancy. Events caused doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The mother reported she became pregnant while taking BNT162B2. The mother was 3 weeks pregnant at the onset of the event. The mother was due to deliver on 17Dec2021, and last menstrual period date was on 12Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Pregnancy loss and fever cannot be excluded.  The case will be reassessed if 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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 13-years-old via an unspecified route of administration, administered in arm right on 22May2021 10:30 (Batch/Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included seasonal allergy and known allergies: lactose intolerance from an unknown date and unknown if ongoing. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and ascorbic acid (VITAMIN C); both taken for an unspecified indication, start and stop date were not reported. The patient fainted within 5 minutes of receiving Pfizer Covid-19 vaccine on 22May2021 10:45 (as reported). The patient recovered from the event on an unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy is acting up; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunization. Medical history included neuropathy. The patient's concomitant medications were not reported. Patient reported that she already has neuropathy but for some reason it was acting up. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (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 got COVID-19 after first vaccination but before the second one. Event took place after use of product. Event outcome was unknown.    Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Got COVID-19 after their first vaccination but before their second one; Got COVID-19 after their first vaccination but before their second one; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date (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 got COVID-19 after first vaccination but before the second one. Event took place after use of product. Event outcome was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: fully vaccinated and diagnosed with COVID and symptomatic; fully vaccinated and diagnosed with COVID and symptomatic; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on an unspecified date as single dose, second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient was fully vaccinated and diagnosed with COVID and symptomatic. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myocardial infarction, Pain, Pain in extremity, Speech disorder
Clinical narrative: pain; heart attack; couldn't talk, the pain was so hard; pain in his left arm; Indigestion; chest pain; small temperature that was one degree higher than before; wiped out tired-extremely exhausted and tired; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in right arm on 13May2021 at 11:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is very strict on his health. The patient is a vegetarian, he is very health conscious. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID vaccine. The patient previously received the first dose of bnt162b2 on Apr2021 for COVID-19 immunization and experienced tenderness at the shot site and was very tired. On the morning of 14May2021, the patient had a small temperature that was one degree higher than before and the patient was wiped out tired-extremely exhausted and tired. Then the patient started experiencing chest pain within days of the second dose. The patient woke up on 15May2021 with chest pain that was persistent through 18May2021. On 19May2021, the chest pain got worse. The reporter thought the patient had indigestion so she gave the patient Tylenol, Pepcid, and clear soda and the patient felt a little better. On 20May2021, the patient was clutching his chest and had pain in his left arm. The patient couldn't talk, the pain was so hard. The patient went to the emergency room at 12:00 and the healthcare team said that the patient was experiencing a heart attack (reported time of heart attack was 10:00). The patient was not admitted to the hospital. They said the chemical that the large muscle in the heart makes, it was elevated which was how they determined it was a heart attack. These lab numbers were drawn every three hours and they came down but never went away. The patient had two Troponin draws and they were both elevated. They also did an EKG on the patient which showed a heart attack. The patient was told to see a cardiologist and was sent home. The reporter is watching the patient and the patient is still in a little bit of pain but not as much. The patient went to his primary care provider on the day of the report and the doctor doesn't see this as a displaced issue. The doctor does not know what would cause this in the heart. The patient is to see the cardiologist on Tuesday, 25May2021. The reporter is unsure if this is related to the vaccine but it was almost a week after the patient's second dose. The outcome of the event small temperature that was one degree higher than before was recovering and the outcome of the event wiped out tired-extremely exhausted and tired was not recovered. The outcome of the other events was unknown.   Information on the lot/batch number has been requested
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: pain; heart attack; couldn't talk, the pain was so hard; pain in his left arm; Indigestion; chest pain; small temperature that was one degree higher than before; wiped out tired-extremely exhausted and tired; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in right arm on 13May2021 at 11:00 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is very strict on his health. The patient is a vegetarian, he is very health conscious. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID vaccine. The patient previously received the first dose of bnt162b2 on Apr2021 for COVID-19 immunization and experienced tenderness at the shot site and was very tired. On the morning of 14May2021, the patient had a small temperature that was one degree higher than before and the patient was wiped out tired-extremely exhausted and tired. Then the patient started experiencing chest pain within days of the second dose. The patient woke up on 15May2021 with chest pain that was persistent through 18May2021. On 19May2021, the chest pain got worse. The reporter thought the patient had indigestion so she gave the patient Tylenol, Pepcid, and clear soda and the patient felt a little better. On 20May2021, the patient was clutching his chest and had pain in his left arm. The patient couldn't talk, the pain was so hard. The patient went to the emergency room at 12:00 and the healthcare team said that the patient was experiencing a heart attack (reported time of heart attack was 10:00). The patient was not admitted to the hospital. They said the chemical that the large muscle in the heart makes, it was elevated which was how they determined it was a heart attack. These lab numbers were drawn every three hours and they came down but never went away. The patient had two Troponin draws and they were both elevated. They also did an EKG on the patient which showed a heart attack. The patient was told to see a cardiologist and was sent home. The reporter is watching the patient and the patient is still in a little bit of pain but not as much. The patient went to his primary care provider on the day of the report and the doctor doesn't see this as a displaced issue. The doctor does not know what would cause this in the heart. The patient is to see the cardiologist on Tuesday, 25May2021. The reporter is unsure if this is related to the vaccine but it was almost a week after the patient's second dose. The outcome of the event small temperature that was one degree higher than before was recovering and the outcome of the event wiped out tired-extremely exhausted and tired was not recovered. The outcome of the other events was unknown.   Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Deafness bilateral, Eye discharge, Lacrimation increased, Vision blurred
Clinical narrative: Loss of hearing in both ears; Weepy left eye that gums up overnight; Weepy left eye that gums up overnight; eyesight sometimes unusually blurry; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that the 52-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: ER8734) as 1st dose, single, dose 2 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced loss of hearing in both ears on Apr2021 with outcome of not recovered, weepy left eye that gums up overnight on Apr2021 with outcome of not recovered, eyesight sometimes unusually blurry on Apr2021 with outcome of not recovered.   The clinical course was reported as follows: The patient  did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination:Breo Ellipta, Singulair. Reported Event: 1. Loss of hearing in both ears - sound is muffled. Feels like sinus's are blocked (but they're not). 2. Weepy left eye that gums up overnight- washes away but eyesight sometimes unusually blurry. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 21May2021.  No follow up attempts are needed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling abnormal, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Extremely dizzy and chances of fainting; Extremely dizzy and chances of fainting; Sweaty; Brain fog/confusion; Brain fog/confusion; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 29Apr2021 (Lot Number: ER8736) at the age of 29-years-old as single dose for covid-19 immunisation.  Medical history included prediabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amoxicillin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced extremely dizzy and chances of fainting, sweaty, brain fog/confusion, all on 20May2021. No treatment received for the events. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 29Apr2021 (as reported), (Lot Number: EW0187) for covid-19 immunisation. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative. Outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Extremely dizzy and chances of fainting; Extremely dizzy and chances of fainting; Sweaty; Brain fog/confusion; Brain fog/confusion; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 29Apr2021 (Lot Number: ER8736) at the age of 29-years-old as single dose for covid-19 immunisation.  Medical history included prediabetes. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amoxicillin within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced extremely dizzy and chances of fainting, sweaty, brain fog/confusion, all on 20May2021. No treatment received for the events. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 29Apr2021 (as reported), (Lot Number: EW0187) for covid-19 immunisation. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative. Outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Rash macular, Vomiting
Clinical narrative: Blotchy skin.; Throwing up; Bells Palsy; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03May2021 (Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included alprazolam (XANAX) and buspirone (BUSPIRONE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination the patient did not diagnosed with COVID-19. The patient experienced blotchy skin, throwing up, bells palsy on 08May2021 18:00. Treatment received for the events. Outcome of events was not recovered. The patient was hospitalized for the events for 2 days. Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Events were reported as serious due to hospitalization, disability. Since the vaccination the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Investigation, Palpitations, Pulse abnormal
Clinical narrative: neck veins constantly pulsates; my Blood pressure rose to 180/100; Heart palpitation; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-year, on 12May2021 17:00 (Lot Number: EW0168) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included ascorbic acid (VITAMIN-C) and Benifber (in two weeks). The patient previously took penicilline and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 1 hour after receiving the Pfizer vaccine (at 18:00 on 12May2021), the patient felt a heart palpitation. The next day occasionally. The 3rd day (On 15May2021), her neck veins constantly pulsates. On the Day 4 (on 15May2021), her blood pressure rose to 180/100. She visited the Emergency room and needed IV bolts Labatalol to bring down BP. And she was hospitalized for 1 day. The patient received treatment included EKG, v-q scan, BP med IV and lovevinox. The patient underwent lab tests and procedures which included COVID test (Nasal swab) on 17May2021 with negative result; D-dimer on an unknown date: 3000 (unknown units). The event outcome was recovered with lasting effects (recovered with sequel).  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: neck veins constantly pulsates; my Blood pressure rose to 180/100; Heart palpitation; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 63-year, on 12May2021 17:00 (Lot Number: EW0168) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included ascorbic acid (VITAMIN-C) and Benifber (in two weeks). The patient previously took penicilline and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that, 1 hour after receiving the Pfizer vaccine (at 18:00 on 12May2021), the patient felt a heart palpitation. The next day occasionally. The 3rd day (On 15May2021), her neck veins constantly pulsates. On the Day 4 (on 15May2021), her blood pressure rose to 180/100. She visited the Emergency room and needed IV bolts Labatalol to bring down BP. And she was hospitalized for 1 day. The patient received treatment included EKG, v-q scan, BP med IV and lovevinox. The patient underwent lab tests and procedures which included COVID test (Nasal swab) on 17May2021 with negative result; D-dimer on an unknown date: 3000 (unknown units). The event outcome was recovered with lasting effects (recovered with sequel).  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be excluded. The case will be reassessed once more information become 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: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: Heart chest pain; Diagnosed within 4 days with Myocarditis Hospitalized; This is a spontaneous report received from a non-contactable consumer (patient). A 17-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm right on 02May2021 at 12:00 AM at age of 17-year-old at single dose for COVID-19 immunization. Medical history included known allergies to Sulfa. Patient also had known allergies to amoxicillin. Other medical history was none. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient didn't receive any other medications within 2 weeks of vaccination. Concomitant medication was none. Patient experienced heart chest pain on 06May2021 at 07:00 AM, and was diagnosed within 4 days with Myocarditis and hospitalized. The events resulted in emergency room/department or urgent care visit and hospitalization. Patient was hospitalized for  6 days. Patient performed echocardiogram and MRI, both with unknown results. Patient received antibiotics and steroids as treatment for the events. Outcome of the events was recovering. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Presyncope
Clinical narrative: I wanna pass out; My stomach hurts; diarrhea; I wanna puke; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in arm right on 19May2021 12:00 at single dose for COVID-19 immunisation. Medical history included empty sella syndrome. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included levothyroxine. Patient previously received COVID-19 Vaccine - Manufacturer Unknown on 27Apr2021 for COVID-19 immunization. The patient's stomach hurt, she had diarrhea, she wanna puke, and wanna pass out on 20May2021 08:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved.  Lot/batch number has been requested. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; numbness sensation; This is a spontaneous report received from a contactable nurse (patient). A 29-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), on 004Mar2021 (at the age of 29-years-old) at unknown, single for COVID-19 immunization. The patient was not pregnant. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. The patient experienced tingling, numbness sensation on 10May2021. The events were reported as serious due to important medical events. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events paraesthesia and hypoaesthesia 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: becoming more severe and then now its spreading throughout entire body on arms thighs legs and chest and belly.; She can't get a good night rest; very itchy and scaling skin; red spots itchy; very itchy and scaling skin; This is a spontaneous report from a contactable consumer (patient).  A 29-years-old female patient received bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine) at 29-years-old, dose 2 via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was none. Historical Vaccine included BNT162B2 on 01Apr2021 at 29-year-old for COVID-19 immunization experienced rash on her right wrist (first dose in left arm Lot Number: EW0150). The consumer reported she took first dose on 01Apr2021 and the second dose on 29Apr2021. On 01Apr2021, about a couple of days after the first dose, the patient started getting a rash on right wrist. She took the shot in left arm. And then afterwards it cleared up a little bit but when she took the second dose on April 29th it actually started becoming more severe and then now its spreading throughout entire body on arms thighs legs and chest and belly. The doctor and prescribed topical steroid cream and said it should go away after a few weeks. There's a lot of itchiness especially at night. Kind of bothersome at night and could not get a good nights rest. Its like eczema very itchy and scaling skin. Most of the parts on body, upper arms its red spots and itchy. Hasn't manifested on to the surface of the skin yet. It got worse 21 days after the second shot.  The event outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate, Heart rate increased, Hyperventilation, Muscle spasms
Clinical narrative: a point of hyperventilation; Breathing started to get rapid; Hands and stomach muscles cramped up as the heart continued to race; Hands and stomach muscles cramped up as the heart continued to race; suddenly both hands started shaking; heart rate increasing, reaching higher than 166; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 12May2021 at 17:00 (at the age of 14-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as no. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours after the vaccine on 13May2021 at 17:00, while seate, suddenly both hands started shaking followed by heart rate increasing, reaching higher than 166 bpm. Breathing started to get rapid to a point of hyperventilation on 13May2021 at 18:00. Hands and stomach muscles cramped up as the heart continued to race on 13May2021 at 18:00. Called 911 and they were able to decrease the hyperventilation through slowed box breathing. They stayed for about 30 minutes as the heat rate slowly decreased to just over 100 bmp on 13May2021. Two other incidents of increased heat rate have happened since in May2021. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all events included hydroxyzine prescribed to induce calming effect as. The outcome of events heart rate increasing, hyperventilation and breathing started to get rapid was recovering; outcome of the other events was unknown. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate, Respiratory rate increased, Tremor
Clinical narrative: a point of hyperventilation; Breathing started to get rapid; Hands and stomach muscles cramped up as the heart continued to race; Hands and stomach muscles cramped up as the heart continued to race; suddenly both hands started shaking; heart rate increasing, reaching higher than 166; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in left arm on 12May2021 at 17:00 (at the age of 14-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as no. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 24 hours after the vaccine on 13May2021 at 17:00, while seate, suddenly both hands started shaking followed by heart rate increasing, reaching higher than 166 bpm. Breathing started to get rapid to a point of hyperventilation on 13May2021 at 18:00. Hands and stomach muscles cramped up as the heart continued to race on 13May2021 at 18:00. Called 911 and they were able to decrease the hyperventilation through slowed box breathing. They stayed for about 30 minutes as the heat rate slowly decreased to just over 100 bmp on 13May2021. Two other incidents of increased heat rate have happened since in May2021. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all events included hydroxyzine prescribed to induce calming effect as. The outcome of events heart rate increasing, hyperventilation and breathing started to get rapid was recovering; outcome of the other events was unknown. This report was reported as non-serious by reporter, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin A increased, Cardiac disorder, Condition aggravated, Ejection fraction
Clinical narrative: Dyssynchronous contraction of IV septum; Elevated IgA; low ferritin; Cardiac MRI showed focal myocardits; Recieved second dose and worsened still/Cardiac MRI showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior); This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 22Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization. Medical history included previous to vaccine had exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury from 2014 and all body damage; autonomic disorder developed causing tachycardia. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), administered in left arm on 01Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization and developed focal myocarditis, Echo in Nov2020 showed no abnormalities, 12 days after first dose on 13Mar2021 vomited clotted blood, hospitalized, cleared and discharged after a day unknown cause of bleeding, elevated HR and BP, now on ivabradine 2.5mg to lower HR to hope to allow heart to heal; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. The patient received second dose and worsened still. After about a month began to normalize. Cardiac MRI on 22Mar2021 showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior in Sep2020). Dyssynchronous contraction of IV septum not previously present either. Elevated IgA and low ferritin on unspecified dates; awaiting hematologist appt. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 which included Nasal swab: Negative on 22Mar2021 and Negative on 10Apr2021. No treatment was received for the events. The outcome of the events was not recovered. Events were reported as serious due to disabling.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction decreased, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 test, Serum ferritin
Clinical narrative: Dyssynchronous contraction of IV septum; Elevated IgA; low ferritin; Cardiac MRI showed focal myocardits; Recieved second dose and worsened still/Cardiac MRI showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior); This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in left arm on 22Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization. Medical history included previous to vaccine had exposure to A. flavus in 2014 with development of fungal ball in sphenoid cavity causing brain injury from 2014 and all body damage; autonomic disorder developed causing tachycardia. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), administered in left arm on 01Mar2021 (at the age of 53-year-old) at single dose for COVID-19 immunization and developed focal myocarditis, Echo in Nov2020 showed no abnormalities, 12 days after first dose on 13Mar2021 vomited clotted blood, hospitalized, cleared and discharged after a day unknown cause of bleeding, elevated HR and BP, now on ivabradine 2.5mg to lower HR to hope to allow heart to heal; difficulty breathing, chest tightness and extreme fatigue to the point of barely being able to walk continued for several weeks. The patient received second dose and worsened still. After about a month began to normalize. Cardiac MRI on 22Mar2021 showed focal myocardits; ejection fraction down to 33/37% (58% 6 months prior in Sep2020). Dyssynchronous contraction of IV septum not previously present either. Elevated IgA and low ferritin on unspecified dates; awaiting hematologist appt. Events were resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, patient had been tested for COVID-19 which included Nasal swab: Negative on 22Mar2021 and Negative on 10Apr2021. No treatment was received for the events. The outcome of the events was not recovered. Events were reported as serious due to disabling.