chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (Severe Tachycardia/ Still very tachycardia) and FEELING ABNORMAL (Felt a little weird). On 03-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Could not get up), ASTHMA (Asthma) and ASTHENIA (Could not get up). On 04-Feb-2021, the patient experienced CONTUSION (Bruise on her right and left leg) and VACCINATION COMPLICATION (Had a reaction to the vaccine). On 01-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low). At the time of the report, DEEP VEIN THROMBOSIS (Venous thrombosis in her left leg/clot was in left leg), TACHYCARDIA (Severe Tachycardia/ Still very tachycardia), DYSPNOEA (Difficulty breathing), FEELING ABNORMAL (Felt a little weird), FATIGUE (Could not get up), ASTHMA (Asthma), CONTUSION (Bruise on her right and left leg), ASTHENIA (Could not get up), VACCINATION COMPLICATION (Had a reaction to the vaccine), HAEMOGLOBIN DECREASED (Hemoglobin decreased) and RED BLOOD CELL COUNT DECREASED (Red blood cells are low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Haemoglobin: low gram per litre (Low) LOW. In March 2021, Red blood cell count: low cells per microlitre (Low) LOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment informations reported were Levalbuterol tartrate  and Rivaroxaba 20 mg   This case was linked to MOD-2021-059897 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Dizziness, Dyspnoea
Clinical narrative: head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing.  The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperhidrosis, Hypoaesthesia, Nausea
Clinical narrative: head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing.  The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: head aches; chills; weird feeling on head; left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb, numbness to both hands; started feeling sweaty; shortness of breath; light headed; nausea; blood pressure drop to 40; The initial was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 23Mar2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 59-years-old via an unspecified route of administration, administered in arm left on 05Jan2021 (Batch/Lot Number: EL1284) as single dose for covid-19 immunisation. Medical history included atrial fibrillation, thyroid problem, hearing problem from an unknown date and unknown if ongoing, Stroke like paralysis from 2014 to an unknown date, gallbladder removal in 2018. Concomitant medications included sotalol, taken for atrial fibrillation from Dec2019 and ongoing; levothyroxine taken for thyroid disorder from 2017 and ongoing; cyanocobalamin (B-12) taken for an unspecified indication from 2014 and ongoing; aspirin [acetylsalicylic acid], taken for an unspecified indication from 2014 and ongoing.  The patient experienced 3-5 minutes after the first dose on 05Jan2021, started feeling sweaty, shortness of breath, light headed, nausea, numbness to both hands. Next day 06Jan2021, wake up with numbness to left hands, head aches, chills, weird feeling in head (back left side of head). This went on for about 2 weeks lasted 1 month got better as days went day. It was also reported that she experienced that her left hand from elbow to finger tips began to numb then few seconds right hand fingers began to numb for period of 2 weeks. Her blood pressure drop to 40 on 05Jan2021. The patient underwent lab tests and procedures which included blood pressure measurement: drop to 40 on 05Jan2021, sars-cov-2 antibody test: 0 (came out 0 antibodies on my blood work had never been expose to anyone with Covid 19) on 24Nov2019, sars-cov-2 test: negative on 08Jan2021. The patient also reported that on 05Jan2021, she received the dose and had a reaction to it, but that same day her mother was taken to the hospital because she wasn't breathing well and she came out positive to Covid, she passed away 14 days after the patient took a test on Covid 08Jan2021 tested negative. She don't know if it was soon to be tested but other family member tested positive. The patient did not receive treatment for the events and was hospitalized due to the events. The patient did not recover from nausea, headache, chills while the outcome of the other events was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Fall, Hypokinesia, Incoherent
Clinical narrative: fell out of his bed; her brother was incoherent when he was found by the ambulance staff; her brother was very weak at the time he was found; Her brother wasn't responsive in his hospital bed; her brother tried to get up from the floor and somehow wiggled under his bed and got stuck; had lost a lot of weight before his fall.; brother had some health problems recently; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6200; expiration date: Jun2021, via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 as single dose for Covid-19 immunisation. Medical history included hypersensitivity and not feeling well. The patient's concomitant medications were not reported. The patient previously took Aleve and Advil and experienced allergy. It was reported that the patient took his first Pfizer COVID-19 Vaccine on Wednesday, 10Mar2021. On Monday, 15Mar2021, the ambulance staff found the patient, who had fallen on either Friday 12Mar2021 or Saturday 13Mar2021. The patient was very weak and incoherent at the time he was found. The patient was in bed and fell out of his bed. He tried to get up from the floor and somehow wiggled under his bed and got stuck. The ambulance staff estimated the patient was on the floor for 2 days before he was found. The patient doesn't drink, do drugs, or smoke. The patient may have a glass of wine every 6 months. It was reported that there was one time when the patient wasn't responsive in his hospital bed. The hospital staff shook her brother, massaged his hand, and yelled really loud in his ear before he became awake. The patient was discharged to a rehab center on 19Mar2021 and was going to be at the rehab center for 20 days. It was also reported that the patient had lost a lot of weight before his fall. The patient had some health problems recently. The outcome of the events weight loss and general discomfort was unknown. The outcome of other events was recovering.  Follow up attempts needed. Further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Weight decreased
Clinical narrative: fell out of his bed; her brother was incoherent when he was found by the ambulance staff; her brother was very weak at the time he was found; Her brother wasn't responsive in his hospital bed; her brother tried to get up from the floor and somehow wiggled under his bed and got stuck; had lost a lot of weight before his fall.; brother had some health problems recently; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6200; expiration date: Jun2021, via an unspecified route of administration, administered in left arm on 10Mar2021 10:00 as single dose for Covid-19 immunisation. Medical history included hypersensitivity and not feeling well. The patient's concomitant medications were not reported. The patient previously took Aleve and Advil and experienced allergy. It was reported that the patient took his first Pfizer COVID-19 Vaccine on Wednesday, 10Mar2021. On Monday, 15Mar2021, the ambulance staff found the patient, who had fallen on either Friday 12Mar2021 or Saturday 13Mar2021. The patient was very weak and incoherent at the time he was found. The patient was in bed and fell out of his bed. He tried to get up from the floor and somehow wiggled under his bed and got stuck. The ambulance staff estimated the patient was on the floor for 2 days before he was found. The patient doesn't drink, do drugs, or smoke. The patient may have a glass of wine every 6 months. It was reported that there was one time when the patient wasn't responsive in his hospital bed. The hospital staff shook her brother, massaged his hand, and yelled really loud in his ear before he became awake. The patient was discharged to a rehab center on 19Mar2021 and was going to be at the rehab center for 20 days. It was also reported that the patient had lost a lot of weight before his fall. The patient had some health problems recently. The outcome of the events weight loss and general discomfort was unknown. The outcome of other events was recovering.  Follow up attempts needed. Further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, SARS-CoV-2 test, Seizure
Clinical narrative: Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Complex seizures; Explosive diarrhea; Profuse vomiting; Chills; sweats; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6207), via an unspecified route of administration in the left arm, on 22Mar2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. 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 included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats on 22Mar2021 at 19:00. All of the events required hospitalization from an unspecified date to an unspecified date for one day. The patient underwent lab tests and procedures which included nasal swab: negative on 22Mar2021. Therapeutic measures were taken as a result of all of the events, which included intravenous fluids. The clinical outcome of complex seizures, explosive diarrhea, profuse vomiting, chills, and sweats was recovered on an unspecified date.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Pooped massive amount of blood; This is a spontaneous report from a non-contactable consumer (patient).   A 21-year-old female patient received bnt162b2 (BNT162B2), at the age of 21-years at vaccination, dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient is not pregnant at the time of vaccination. On 24Mar2021 12:00, patient pooped massive amount of blood with outcome of unknown.    Information about lot/batch has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Seizure
Clinical narrative: He had 2 seizures that following Monday, 08 Feb 2021 and another seizure on Friday, 12 Feb 2021.; discovered he had COVID; discovered he had COVID; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 61 years old as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient received his first dose of Pfizer's COVID vaccine on 06Feb2021. He had 2 seizures that following Monday, 08Feb2021 and another seizure on Friday, 12Feb2021. He also stated he discovered he had COVID. He was at the hospital for the seizures and diagnosed with Covid. He was due for the second dose which was supposed to be given the third week. He he spoke to the nurses there and they advised him not to do anything until after 90 days or something like that. He was told by the doctor that his second dose should be delayed until 30 to 90 days and heard from Department of Health that he had up to 42 days that he'll be ok. He stated that he just spoke to themDepartment of Health. He stated that they said after 40 or 42 some odd days, and there was an extra 7 days of leeway, he could get the second dose. He stated that his 42 days was up either today (24Mar2021) or yesterday (23Mar2021). He had an opportunity this Friday (26Mar2021) to get the second shot. He had to get the shot at the same location. He was tired of this. The patient stated when should he take the second shot? Should he wait the 90 days? He stated his primary said to see a neurologist, but he didn't see them until 05May2021 and the neurologist said they couldn't say anything because he was a new patient until they see him, so they say to go to his primary care. Dates for tested positive for covid after first dose of Covid Vaccine was unspecified. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: passed out; feel faint; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient felt faint and passed out after receiving dose, pharmacist asking if need to re administer although received dose. The outcome of the events was unknown.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Parosmia
Clinical narrative: Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia.  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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Condition aggravated, Dyspnoea, Feeling hot, Flushing
Clinical narrative: This is a spontaneous report received from a contactable Consumer, the patient. A 53-years-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, lot number, expiration date: not available) via an unspecified route of administration on left arm on 24Mar2021 09:15 at single dose for COVID-19 immunisation. The patient's medical history included Gastroparesis, allergies to medications, food, or other products: latex, yeast, wheat, guafanisen and Dextromethorphan. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 09:15 AM, patient experienced anaphylaxis within minutes of having the injection and began to feel flushing down throat, then down to chest. That was concerning but when suddenly, patient got really hot, ripped her mask off, and she realized that she was having difficulty breathing and it got worse as time went on, it was resulted in Emergency room/department or urgent care. Patient received Epi-pen, Benedryl, fluids as the treatment for the events. The outcome for the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Sore throat; body ache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unknown route of administration on 17Mar2021 at 10:00 AM (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 at 03:00, the patient experienced sore throat and body ache. The seriousness criteria includes prolonged hospitalization. The patient did not receive any treatment for the events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Disturbance in attention, Mental impairment
Clinical narrative: diminished alertness/clouded headedness; mental acuity reduced; reduced attention to details; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diminished alertness/clouded headedness, mental acuity reduced, and reduced attention to details on an unspecified date. The clinical outcome of the events was recovered on an unspecified date.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: patient experienced headache; This is a spontaneous report received from a contactable nurse. A 88-year-old non-pregnant female patient received BNT162B2 (Solution for injection) via intramuscular route on an unknown date in Mar2021 (second dose) at an unknown dose, single for COVID-19 immunization. Relevant medical history included glaucoma. Historical vaccine included BNT162B2 in Mar2021 for Covid-19 immunization at the age of 88-years. The concomitant medications were not reported. Prior and since the vaccination, the patient was not diagnosed with COVID-19. On 24Mar2021, patient experienced headache. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Pain in extremity, Pyrexia, Syncope
Clinical narrative: Mild syncope; Mild syncope; Low grade fever; Arm soreness 1st 24 hours; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN9581), via an unspecified route of administration in left arm on 02Mar2021 13:30 (at the age of 69-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's first dose of bnt162b2 (lot not reported) (at the age of 68-years-old) in left arm on 01Feb2021 at 14:00 for Covid 19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have other vaccines within 4 weeks prior to the COVID vaccine. Medical history included mild syncope episodes and pacemaker. The patient had no allergies to medications, food, or other products. Concomitant medications included alondranate, calcium, metropolol and an unspecified multi vitamin. The patient experienced arm soreness in the first 24 hours on 02Mar2021. Mild syncope and low grade fever 20 days after dose 2 (on 21Mar2021 at 13:00). The treatment received for the adverse events was paracetamol (TYLENOL). The outcome of all events was recovered on 03Mar2021 for pain in extremity and in Mar2021 for the rest of the events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Foetal hypokinesia, Headache, Maternal exposure during pregnancy, Pain
Clinical narrative: decrease in fetal movements; body aches; decrease in fetal movements; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and fetus/baby. This is the mother report.  A 30-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 22Mar2021 at 5:30, the patient experienced decrease in fetal movements, body aches and had a slight headache. The mother reported she became pregnant while taking bnt162b2. The mother was 37 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.  Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326788 same report/drug, mother/child case
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep vein thrombosis in the left calf; This is a spontaneous report received from a contactable consumer (patient).  A 73-year-old male patient received the second single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 06Feb2021 (Lot Number: EM9810), at the age of 73 years old, for COVID-19 immunisation. The patient had previously received the first single dose of BNT162b2 in the left arm on 16Jan2021 (lot number: EL8482). The patient had not received any other vaccines within 4 weeks prior to the BNT162b2 administration. Prior to vaccination, the patient had never been diagnosed with COVID-19. The patient's medical history included essential thrombocythaemia and benign prostatic hyperplasia. There were no allergies to report. Concomitant medications included hydroxyurea, simvastatin, mirtazapine, and acetylsalicylic acid (ASPIRIN). The patient stated developing deep vein thrombosis in the left calf on 15Feb2021, at 06:00 (10 days after 2nd shot), requiring a visit to ER. The patient was treated with enoxaparin (LOVENOX), followed by dabigatran etexilate (PRADAXA). Since the vaccination, the patient not been tested for COVID-19. The patient was recovering from the event.   Follow-up Information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Deep vein thrombosis in the left calf; This is a spontaneous report received from a contactable consumer (patient).  A 73-year-old male patient received the second single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 06Feb2021 (Lot Number: EM9810), at the age of 73 years old, for COVID-19 immunisation. The patient had previously received the first single dose of BNT162b2 in the left arm on 16Jan2021 (lot number: EL8482). The patient had not received any other vaccines within 4 weeks prior to the BNT162b2 administration. Prior to vaccination, the patient had never been diagnosed with COVID-19. The patient's medical history included essential thrombocythaemia and benign prostatic hyperplasia. There were no allergies to report. Concomitant medications included hydroxyurea, simvastatin, mirtazapine, and acetylsalicylic acid (ASPIRIN). The patient stated developing deep vein thrombosis in the left calf on 15Feb2021, at 06:00 (10 days after 2nd shot), requiring a visit to ER. The patient was treated with enoxaparin (LOVENOX), followed by dabigatran etexilate (PRADAXA). Since the vaccination, the patient not been tested for COVID-19. The patient was recovering from the event.   Follow-up Information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site irritation
Clinical narrative: was "almost like cellulitis."; arm "turned beet red"; This is a spontaneous report from a contactable consumer reported for her friend. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 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 and concomitant medications were not reported.  he patient reported "almost like cellulitis" (medically significant) on an unspecified date with outcome of unknown ,and arm "turned beet red"  on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Diplopia, Dizziness, Dysgeusia, Dysphagia
Clinical narrative: face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer.   A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.  Additional Information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Pain
Clinical narrative: face felt like plastic; Acute pain in base/spine of neck; dizziness; difficulty breathing & swallowing; difficulty breathing & swallowing; nausea; metallic taste in mouth; double vision; This is a spontaneous report from a contactable consumer.   A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm on 18Mar2021 at 08:15 (Batch/Lot Number: EP7534) as a single dose at the age of 49, for Covid-19 immunisation. Medical history included juvenile- als, and a sulfa allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 18Mar2021, after use of product patient developed Acute pain in base/spine of neck, dizziness, difficulty breathing & swallowing, nausea, metallic taste in mouth, face felt like plastic, double vision. The patient was not hospitalized nor was treatment received for the events. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.  Additional Information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Choking, Dyspnoea, Erythema
Clinical narrative: Anaphylactic reaction; choking; could not breathe; legs have been red; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife). A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunisation. The reporter stated that the patient never had allergies, not until she took the Pfizer covid-19 vaccine. Concomitant medications were not reported.   On an unspecified date, the patient had an Anaphylactic reaction after first dose and started choking and could not breathe. The reporter also stated they gave her two shots in her legs of Adrenaline right after first dose of covid-19. The reporter then stated his wife went to the hospital and was prescribed medication which than gave her allergies and her legs have been red since taking medication. Treatment was received for the events, Anaphylactic reaction, started choking and could not breathe. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 20Mar2021 08:30 as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial and allergies: cat and bee stings. Concomitant medications included prednisone epinephrine, and chlorphenamine maleate (ANTIHISTAMIN) taken. Patient was not pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID prior to vaccination. After about 30 minutes, on 20Mar2021 09:00 AM, the patient experienced tongue started swelling and would not subside. She tried antihistamine all day with no success. She went to Urgent Care and received steroid shot and was prescribed prednisone that same evening. She was told to return if symptoms not improved in three days. The patient returned on Monday evening and was sent to the ER. She was diagnosed with Angioedema and given more antihistamines and steroid shot and epinephrine in IV. The patient was currently monitoring and seeing an allergist to follow up. Her tongue was still not back to normal. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of tongue started swelling and would not subside was not recovered, and of angioedema was unknown. The events were reported as non-serious. The patient had not been been tested for COVID-19 since the vaccination. No follow-up attempts are possible; information on the batch/lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Arrhythmia episode; This is a spontaneous report from a contactable consumer (patient). A 68-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6205), via an unspecified route of administration, on 03Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included occasional palpitation episodes which has been self-terminating. The patient's concomitant medications were not reported. The patient had the first COVID-19 shot and had some questions about possible side effect from that. The patient was a healthy person but in the last several years I have had occasional palpitation episodes which has been self-terminating. Anyway, the day after the patient's first COVID-19 shot (04Mar2021), the patient had arrhythmia episode and that was unusual for the patient and it lasted till 3:00 PM. The patient didn't have in several months and since then, the patient had four more episodes. Now, the only thing the patient wanted to mention is that it (arrhythmia) started on 04Mar2021 and on 05Mar2021, the patient started to take unspecified (as voice not clear), so that is going on. The patient had the second shot scheduled this afternoon, so the patient's question is if it is safe to get that or should the patient be suspicious about these episodes. The outcome of the event was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dysphagia, Dysphonia, Throat irritation, Wheezing
Clinical narrative: My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dysphonia, Heart rate, Hypersensitivity, Investigation
Clinical narrative: My throat was itchy in between that half hour my voice started to change; my throat felt worse; I have wheezing in my lungs; I still have problem swallowing a little bit; My throat was itchy in between that half hour my voice started to change; my throat felt worse; This is a spontaneous report from a contactable consumer (reporting for herself). A 60-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included anxiety, depression, neuralgia, heart, blood pressure issue and lot of allergies. Concomitant medication included levothyroxine; atorvastatin calcium (CHOLESTAT [ATORVASTATIN CALCIUM]); pantoprazole; ciprofloxacin hydrochloride, tinidazole (FLOXAZOLE); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); lubiprostone (AMITIZA); thioctic acid (ALPHA LIPOIC ACID); baclofen; linezolid (ZENIX [LINEZOLID]); ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]); rosuvastatin calcium (CRESTOR); docusate sodium (STOOL SOFTENER); benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE) taken for heart; desvenlafaxine succinate (PRISTIQ) taken for anxiety, depression; citalopram; venlafaxine hydrochloride (EFFEXOR) taken for anxiety; escitalopram oxalate (LEXAPRO); cyclobenzaprine; gabapentin taken for neuralgia; metoprolol taken for heart; amlodipine taken for blood pressure issue; magnesium oxide. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Feb2021 for COVID-19 immunization and experienced pulse rate would not go down. On 15Mar2021, it was reported that they had it done at the hospital, then after 15 minutes, her throat was itchy the may say another half hour in between that half hour, her voice started to change and her throat felt worse. They walk me down to the ER my throat was hurting then slowly they gave me Epi Pen and they injected in an IV with steroids. The have wheezing in her lungs and spent the night in hospital for observation. They did all kind of blood work, when she was placed in ER. The patient reported that she still have problem swallowing a little bit and voice changes after talking. The outcome of the event "still have problem swallowing a little bit" was not recovered while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.