chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Tingling lips; I thought maybe they (lips) were swollen just a little bit; Swelling in the left side of neck either in a lymph node or in that gland; Swelling in the left side of neck either in a lymph node or in that gland; Had some tightness when I was breathing deep, some tightness in lungs; Itching lips; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 11:45 AM at single dose for COVID-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. In Jan2021 the patient had first Pfizer shot on Sunday at 11:45 AM. And then did not have any reaction to it that day. But later that night and early Monday morning had a little bit of tingling in lips and thought maybe they (lips) were swollen just a little bit. And had some swelling in the left side of neck either in a lymph node or in that gland. Then patient reported a little bit of swelling thought it was with the lymph node. And then had some tightness like when was breathing deep, some tightness in lungs. The patient asked if these are considered severe reactions or they just minor or what are they. The tingling in lips only lasted for just for itching or what, it only lasted only for a little while and the lymph node went back down after an hour or so. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: got a cold for the day; This is a spontaneous report from a contactable consumer   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was informed that patient experienced got a cold for the day on an unspecified date. At the time of the reporting event outcome was unknown.   The information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Influenza like illness, Insomnia
Clinical narrative: Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Chills; Body aches; Barely able to move his arm; He feels horrible/not feeling well; He can't sleep; Ringing in the ears; Nausea; Flu like symptoms; Bad sore arm; Muscle aches; Joint pain; This is a spontaneous report from a contactable consumer (mother of the patient). The same consumer reported information for 3 patients. This is the first of 3 reports. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 at single dose for COVID-19 immunisation at the age of 41-year-old. Medical history and concomitant medications were unknown. On 25Jan2021, the patient experienced Flu like symptoms, He had a bad sore arm, barely able to move his arm, Nausea, Muscle ache, Joint pain; no fever. On unknown date, the patient experienced not feeling well/ feels horrible, chills, body ache. Patient stayed home from work one day. On 27Jan2021, the patient felt a little better, but he still would have the symptoms. On 28Jan2021, the patient had ringing in the ears, he has muscle aches, he could not sleep. Patient reportedly as very well young man and he has no medical problems. The patient was recovering from the events. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Feeling hot, Peripheral swelling
Clinical narrative: got the shot in the upper arm but on his forearm it looked like he had cellulitis; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; It was all red and swollen and warm on touch; This is a spontaneous report from a non-contactable consumer.  A male patient (reporter's father) of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated the patient got the shot in the upper arm but on his forearm it looked like he had cellulitis. It was all red and swollen and warm on touch. The reporter didn't know if that's the side effects from the vaccine or not. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Dementia, Dizziness, Dyspnoea
Clinical narrative: Dementia; He has a temperature of 100.7; Labored breathing/Very hard time breathing; Dizziness; He has been freezing all day, he is so cold; Pulse 84; This is a spontaneous report from a contactable consumer and a non-contactable consumer. This consumers (patient's son and wife) reported that a 92-years-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Medical history included allergic to Penicillin.  The patient's concomitant medications were not reported.  The patient had his Covid19 vaccination on the 29Jan2021 last Friday, he had dementia, he had a temperature of 100.7, pulse 84, labored breathing, dizziness in Jan2021 and so the son asked if this was a normal reaction he was also allergic to Penicillin. The patient had been freezing all day, he was so cold and they had been giving him a lot of water and he had a temperature tonight (as reported) and had very hard time breathing in Jan2021. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Heart rate, Pulse abnormal
Clinical narrative: Dementia; He has a temperature of 100.7; Labored breathing/Very hard time breathing; Dizziness; He has been freezing all day, he is so cold; Pulse 84; This is a spontaneous report from a contactable consumer and a non-contactable consumer. This consumers (patient's son and wife) reported that a 92-years-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. Medical history included allergic to Penicillin.  The patient's concomitant medications were not reported.  The patient had his Covid19 vaccination on the 29Jan2021 last Friday, he had dementia, he had a temperature of 100.7, pulse 84, labored breathing, dizziness in Jan2021 and so the son asked if this was a normal reaction he was also allergic to Penicillin. The patient had been freezing all day, he was so cold and they had been giving him a lot of water and he had a temperature tonight (as reported) and had very hard time breathing in Jan2021. The outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Nerve injury, Pain
Clinical narrative: Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization.  The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own.  Caller states that this is not going away.  She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Sleep disorder due to a general medical condition, Somnolence
Clinical narrative: Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization.  The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own.  Caller states that this is not going away.  She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Nerve injury
Clinical narrative: Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization.  The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own.  Caller states that this is not going away.  She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal ganglia stroke, SARS-CoV-2 test
Clinical narrative: Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal ganglia stroke
Clinical narrative: Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Laboratory test, Magnetic resonance imaging brain abnormal, Vascular rupture
Clinical narrative: Basal Ganglia sudden stroke; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 30Jan2021 at 13:00 (at the age of 55-years-old) at a single dose for COVID-19 immunization. The patient had no medical history and no blood pressure condition. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included an unspecified thyroid medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced basal ganglia sudden stroke on 30Jan2021 at 13:00, which prolonged hospitalization, caused disability, and was reported as life-threatening. The vaccine was received during existing hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 03Feb2021. Therapeutic measures were taken as a result of the event, which included intensive care unit (ICU) neurocare. The clinical outcome of basal ganglia sudden stroke was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Death, Platelet count decreased
Clinical narrative: a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine; The is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient (doctor) died of low platelet and brain bleed 16 days after the vaccine. It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: a doctor died of low platelet and brain bleed 16 days after the vaccine; a doctor died of low platelet and brain bleed 16 days after the vaccine
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site swelling
Clinical narrative: was administered into the Deltoid Tuberosity area instead of the deltoid itself; patient was concerned about the vaccine having been given SubQ instead of IM; there was a little bit of bleeding; the patient noticed a little bit of bruising; and a little bit of swelling; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, Expiry Date: May2021), subcutaneously on 28Jan2021 14:45 at 0.3mL single dose into the left deltoid tuberosity for COVID-19 immunization. Vaccination Facility Type was at Health Clinic. The patient's medical history and concomitant medications were not reported. Caller was an LVN and she had a vaccination clinic and there was an incident where one of the COVID vaccines that was administered to a patient, was administered into the Deltoid Tuberosity area instead of the deltoid itself. Caller stated that the patient was concerned about the vaccine having been given SubQ instead of IM. Caller was calling to find out how effective it would be if it was given SubQ. Caller stated that the patient was married to a doctor, and was a Nurse Practitioner herself, so she did not need to seek treatment. Caller stated that the patient was able to assess it herself, the patient noticed a little bit of bruising, but she suspected there would be, because there was a little bit of bleeding, and a little bit of swelling on 28Jan2021. The outcome of the events were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising, Vaccination site pain
Clinical narrative: was administered into the Deltoid Tuberosity area instead of the deltoid itself; patient was concerned about the vaccine having been given SubQ instead of IM; there was a little bit of bleeding; the patient noticed a little bit of bruising; and a little bit of swelling; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261, Expiry Date: May2021), subcutaneously on 28Jan2021 14:45 at 0.3mL single dose into the left deltoid tuberosity for COVID-19 immunization. Vaccination Facility Type was at Health Clinic. The patient's medical history and concomitant medications were not reported. Caller was an LVN and she had a vaccination clinic and there was an incident where one of the COVID vaccines that was administered to a patient, was administered into the Deltoid Tuberosity area instead of the deltoid itself. Caller stated that the patient was concerned about the vaccine having been given SubQ instead of IM. Caller was calling to find out how effective it would be if it was given SubQ. Caller stated that the patient was married to a doctor, and was a Nurse Practitioner herself, so she did not need to seek treatment. Caller stated that the patient was able to assess it herself, the patient noticed a little bit of bruising, but she suspected there would be, because there was a little bit of bleeding, and a little bit of swelling on 28Jan2021. The outcome of the events were unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Dizziness, Feeling cold, Myalgia
Clinical narrative: At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Purpura, Rash pruritic
Clinical narrative: rash all over his back and it itched like crazy and then started bleeding; rash all over his back and it itched like crazy; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot # EK4176, via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation.  Medical history included heart disorder from an unknown date. Concomitant medications included a lot of medications for his heart and stuff. In Jan2021 the patient experienced rash all over his back and it itched like crazy and then started bleeding when he scratched. He received Benadryl tablets lotion on it as treatment. The outcome of the events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between  event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Syncope
Clinical narrative: syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between  event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disease recurrence, Dizziness, Fatigue, Pain in extremity
Clinical narrative: had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: had to close my eyes due to the faint feeling; palpitation; Fatigue; chills in the back of the head; Arm soreness; felt a mild palpitation but not as strong as the strong one I experienced after the first injection/Arm soreness was much less than after the first dose/Fatigue was comparable; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), via an unspecified route of administration in right arm on 26Jan2021 12:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization and experienced palpitation, Arm soreness and Fatigue. 30 min after injection, the patient felt a mild palpitation-stronger than any previous mild ones but not as strong as the strong one he experienced after the first injection, and he had to close his eyes due to the faint feeling. This was followed by a mild one 3 min later. In the next few days he had several additional mild to weak palpitations. The strong one that he experienced 12-14 hours after receiving the first dose did not show. Arm soreness was much less than after the first dose. Fatigue was comparable, and in third day still had to take a nap immediately after the breakfast. Additional nap was taken during the day-needed more but did not have time. The patient felt some chills in the back of the head some days but did not get "sick" at all. All events occurred on 26Jan2021 13:00. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient had no COVID prior vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Jan2021.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: allergic to the flu shot; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves adult patient who was allergic to the flu shot (Allergy to vaccine), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic to the flu shot (Allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that the patient was not taking any chances on the COVID (corona virus disease) vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No relevant laboratory tests were reported.  It was not reported if the patient received any corrective treatment.  The outcome of the event was unknown at the time of reporting.  There will be no information available on batch numbers.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: ill; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was ill (illness), when received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), past vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was ill (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient felt ill after getting flu shot every time for at least one day usually 2.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: miserably sick; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was miserably sick (illness) when received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), past vaccination(s) and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was miserably sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient received vaccine for 3 years and got miserably sick for 2-3 weeks each time. The patient stopped getting the shot and it has been over 30 yrs. It is different on each individual   It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available   It was not reported if the patient received a corrective treatment.  At the time of report, the event recovered.  There will be no information available on the batch number for this case
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: become deathly ill; Initial information was received on 13-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who become deathly ill (illness), when received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), past vaccination(s) and family history were not provided    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient become deathly ill (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States.  This case involves female patient of an unknown age who experienced flu (influenza), while she received vaccine INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment, vaccination concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that got her flu shot. She got the flu. Medication details and reason for taking the medicine: not provided.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.  There will be no information available on the batch number for this case.