chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Insomnia, Pain
Clinical narrative: pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned there were also 2 children and 2 adults who were positive. Clarified later in call that they were all at a dinner party together with 4 adults vaccinated and 2 unvaccinated children, one being her daughter (adult) and niece and they both also tested positive for Covid virus, which she finds profound. Stated her daughter received the Pfizer Covid vaccine, but her niece was not vaccinated and was just positive for Covid virus. Mentioned she just read that the CDC is only interested in post vaccination serious cases. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Nephrolithiasis, Thirst
Clinical narrative: kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable consumer (patient). A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10May2021 14:00 (Lot Number: EW0168) as single dose (at the age of 19-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA), all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 02:00 PM  (Lot Number: EW0162) as single dose (at the age of 19-years-old) for COVID-19 immunization and experienced Heavy period off schedule from pill pack. The patient experienced extreme thirst since second dose (10May2021). Then, on 27May2021, had severe left flank pain causing an emergency room visit. Preliminary diagnosis is kidney stones. At ER, patient received pain medication, saline hydration drip. The outcome of the events was recovering. The event kidney stones was considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are possible; further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Hypersomnia, Suicidal ideation
Clinical narrative: I feel like to commit suicide, I feel that terrible; I have lost all of my appetite; Have been sleeping 14 hours a day since I had that second dose of vaccine; can't eat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 20Apr2021 for COVID-19 Immunization. In May2021, the patient had lost all of appetite and had been sleeping 14 hours a day since having the second dose of vaccine. This got the patient, felt like to commit suicide, the patient felt that terrible (not clarified further, event captured as per verbatim) and the patient can't eat. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Two strokes; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced two strokes on an unspecified date within a week of receiving the first dose. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced two strokes (within a week of receiving first dose). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced two seizures after receiving second dose. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Seizure
Clinical narrative: Three strokes; Two seizures; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Caller complaining about Vaccine, she wanted to report Pfizer for the vaccine causing her three strokes, two seizures within a week of receiving first dose (unspecified date). Caller Disconnected shortly after being taken off hold to be referred to a facility. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: 32 day after vaccination I developed Bell's Palsy.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158; Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24Apr2021 13:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included diabetes. Patient had known allergies to penicillin. Concomitant medication included metformin. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: unknown, Formulation: solution for injection), via an unspecified route of administration, administered in arm right on 03Apr2021 at 13:15 as single dose for covid-19 immunisation with no adverse effect. Patient developed bell's palsy 32 day after vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received metformin within 2 weeks of vaccination. Patient developed bell's palsy 32 day after vaccination. These adverse event result in emergency room/department or urgent care. Patient was treated with anti viral prescription. Patient was not diagnosed with covid-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered.    Follow up needed, further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report from a non-contactable consumer received from other company, Mylan (Case ID: GI-2021-5625). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date. The outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: bleeding from her eye; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported that a female patient of unspecified age received first and second single doses of BNT162B2 (Pfizer Covid-19 Vaccine) for COVID-19 immunization; route and therapy dates were unspecified. Medical history included bleeding disorder. Concomitant medications were not reported. The patient had a bleeding disorder and when she received both doses, she started bleeding from her eye on an unspecified date. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Faeces discoloured
Clinical narrative: her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color.; her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for covid-19 immunisation. On an unspecified date in May2021, the patient noticed that her stool is black, a bit of "diarrhea but not diarrhea" as verbalized. Then the next stool is red liquid in color. The patient asked if this was a side effect of the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Patient got sick from Covid Vaccine Pfizer Feb2021 her lungs filled with fluid did not get 2nd dose; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got sick from Covid Vaccine Pfizer Feb2021 her lungs filled with fluid did not get 2nd dose (as reported) with outcome of unknown.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Disease recurrence
Clinical narrative: I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; I had history of Bells Palsy and it occurred in Dec2009.Similar symptoms of Bells Palsy started on 29May2021, 2 weeks after the Covid 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12May2021 10:45 (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation. Medical history included bell's palsy in Dec2009. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 (Batch/Lot Number: EB8731) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that he had history of Bells Palsy and it occurred in Dec2009. Similar symptoms of Bells Palsy started on 29May2021 at 7:00 AM, 2 weeks after the Covid 2nd dose. The patient consulted his physician and on medications (Steroid and Anti-infamotroy(inflammatory)) now. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pancreatitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: pancreatitis; Fever102; felt lousy; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:15 as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure, hypothyroid, osteoporosis, and allergies: Bactrium, kelflex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); valsartan (DIOVAN).  On 18Mar2021 16:00, the patient experienced Fever102 felt lousy, 10 days later had pancreatitis and spent 4 days in hospital. She had never had pancreatitis before. All scans showed no gallbladder cause, she did not drink. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab: negative on 05May2021. Treatment received for the adverse event included Iv fluids pain meds. The outcome was recovered with sequel. This case was reported as serious, life threatening, caused/prolonged hospitalization.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021.  even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing  for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, SARS-CoV-2 test, Syncope
Clinical narrative: I almost got fainted or black out; My blood pressure and heart rate dropped to 76/55/42 respectively; My blood pressure and heart rate dropped to 76/55/42 respectively; Sweaty; Clammy; This is a spontaneous report from a contactable consumer. This 45-year-old male consumer (patient) received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration administered in arm right on 27May2021 12:26 (Batch/Lot Number: EW0180) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received first Pfizer dose in his right arm at 12:26 PM on 27May2021.  even minutes after vaccination, at 12:33 PM, he almost got fainted or black out. His blood pressure and heart rate dropped to 76/55/42 respectively. The patient was sweaty and clammy for about 3 minutes. At 12:40 PM, his blood pressure and heart rate elevated to 103/69/65. At 1:05PM, his blood pressure and heart rate came back to normal 120/84/67. The patient drove home afterwards without further reaction. He was a heathy male with no underline health condition. The patient have been testing  for COVID-19 once a week since 07May2021 and all test results came back negatives (on 28May2021). The events result Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The outcome of blood pressure and heart rate dropped was recovered on 27May2021 1:05PM, of other events was recovered in May2021. No treatment was received for the events.
Sex: F
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: Coma; This is a spontaneous report from a contactable consumer.   A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unknown date, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient went into a coma after the COVID-19 vaccine. The coma happened 24 hours after the patient got the vaccine. The reporter thought patient's coma was due to vaccine. The reporter stated that the patient is still in the coma but he is unsure. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I had Bells Palsey a few years ago and the symptoms came back very minor but hasn't gotten any better. Not complete paralysis on my fight side of face but reduced strength by more than 50%; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in right arm on 08Apr2021 at 14:15 as single dose for COVID-19 immunization. Medical history of the patient included Bell's palsy (a few years ago) and known allergies (nine patient is aware of). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) for an unspecified indication. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 25Mar2021 at 14:15 as single dose for COVID-19 immunization. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 09Apr2021 at 05:00, 14 hours 45 min after receiving second dose of vaccination, the symptoms of Bell's palsy came back very minor but had not gotten any better, not complete paralysis on patient's right side of face but reduced strength by more than 50 per cent. Outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia
Clinical narrative: I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; I experienced facial numbness and paralysis. As per Doctor it's Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176), via an unspecified route on 03May2021 at 14:30 (at the age of 48-years) as 2nd dose, single dose in the left arm for covid-19 immunisation. The patient medical history included chronic lymphocytic leukaemia. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included rivaroxaban (XARELTO). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route on Apr2021 at 14:30 as 1st dose, single dose in the left arm for covid-19 immunisation. On 28May2021, the patient experienced facial numbness and Paralysis. As per doctor it's bell's Palsy. The patient received treatment for events with prednisone and valacyclovir. The patient visited physician office. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dementia, Dysstasia
Clinical narrative: This is a spontaneous report from a contactable consumer (husband) reported for a female patient (wife).  A female patient of unspecified age and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number and expiration date: Not reported), via an unspecified route of administration on an as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 on an unknown date for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date it was reported that the patient experienced Dementia. The caller stated that since the patient received her second vaccine shot, she seemed to be so weak and she cannot stand up on her own feet. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Eye disorder, Muscle twitching
Clinical narrative: I guess it was like bell's palsy and I had it happened to me three times, two times in one day and then one time like a couple days later; Mouth twisting; Eye closing; This is a spontaneous report from a contactable consumer or other non hcp reported herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 14:15 (Batch/Lot Number: EW0185) as a Single dose for covid-19 immunization. The patient past Medical history included asthma. The concomitant medication was reported as no. the patients historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 29Apr2021 (Batch/Lot Number: EW0167) as a Single dose for covid-19 immunization. The patient was not administered another vaccine within 4weeks prior. On 26May2021, after the second dose of her vaccine the patient experienced side effect of the mouth twisting, eye closing and she couldn't like, she guesses it was like bell's palsy and she had it happened to her three times at 5:30 in the morning and then again at 8:45 when she went to work and then she had to go to the emergency on the Wednesday and then again on the 28th in the morning at about 6 O'clock in one day and then one time like a couple days later. The patient confirmed went to emergency, stated, "she called the advice nurse and they said nothing was going on like when they did there, but she had her, when she was at work, she had people who seen it happening to her. So that was a good thing because as it met, she doesn't think that people would believe that it happened to her and she didn't want to take the shot just because of the side effects. But due to her job policy that we had to take it, so that's why she took it to keep her job. Consumer stated, "No, they didn't do anything for me.". The outcome is Recovered on an Unspecified date in 2021.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171, expiration date not reported), via an unspecified route of administration, administered in Left arm on 30Apr2021 14:00 (at the age of 30-years-old) as 2nd dose, single dose for covid-19 immunisation. Medical history was reported as none and the patient had no known allergies. The patient did not receive other medications in two weeks of vaccination. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732) via an unspecified route of administration, administered in Left arm on 09Apr2021 14:00 as 1st dose, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 21May2021 at 16:00, the patient experienced Bell's palsy and was treated with Antiviral / steroid prescription. The adverse event resulted in emergency room/department or urgent care. The reporter assessed event as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused or prolonged hospitalization, Disabling or Incapacitating, Congenital anomaly or birth defect. The outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0179, Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 03May2021 at 10:15 (at the age of 31-year-old) as single dose for covid-19 immunization. The patient's medical history and known allergies were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO); vitamin D NOS [VITAMIN D] and vitamin B complex (VITAMIN B). The patient previously received first dose of BNT162B2 (Lot number: ER8731) via an unspecified route of administration, administered in left arm on 12Apr2021 at 10:15 for COVID-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 14May2021 at 20:00, the patient was diagnosed with Bell's Palsy. Treatment received for the adverse event included Steroid pills and antibiotics for 1 week. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event. Since the vaccination the patient had not been tested for COVID-19. The outcome of the event was resolving.  Device Date: 01Jun2021
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pruritus, Swelling face, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) and other healthcare professional. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:00 (at the age of 29 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. There was no patient history and no family medical history relevant to adverse event.  Reported to be no other products and no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No Adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient wanted to know if she was considered fully vaccinated after receiving just 1 dose of the Pfizer-BioNTech Covid-19 Vaccine. The patient stated that she worked in health care around people and she got the vaccine to protect herself and others. The patient reported that she had a reaction after the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on Thursday, 27May2021. She said her face became swollen, she broke out in hives, and had itchiness. The patient stated that her face began to swell 2 or 3 hours after she had vaccine and stated that she was taking Benadryl like candy and the reactions went away on Friday afternoon for good. The patient also reported that swelling, itching and hives also happened at the same time after the vaccine and went away on Friday afternoon. The adverse event did not require a visit to emergency room/physician office and the patient was not hospitalized. The patient stated that she had an EpiPen at home and Benadryl. If it got too bad, she would have taken her EpiPen and gone to the emergency room. She said her doctor told her not to get the 2nd dose. She asked if that would put her as not fully vaccinated. She was trying to figure out how that would work. Should she try another company like Johnson and Johnson even though they are not supposed to be mixed, or was she considered exempt. The patient wanted to know if she should try to get a vaccine from a different company like Johnson & Johnson, and how it would affect the Pfizer-BioNTech Covid-19 Vaccine that she previously had. It was reported that, there were no relevant tests and no investigation assessments done. The clinical outcome of the events her face became swollen, hives, itchiness was recovered on 28May2021 and event if she should try to get a vaccine from a different company like Johnson & Johnson was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis, Syncope
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Xeljanz Program from a contactable nurse and a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) 11mg, via an unspecified route of administration from Dec2020 and ongoing (Lot Number: EH9982) at 11 mg for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date patient experienced lightheadedness, tired, overheating and breaking out in sweat. On 16Apr2021 she felt like throwing up and fainted. Patient reported experiencing lightheadedness, really tired and felt like overheating and breaking out in sweat. Patient also reported a month and a half before the time of the report, on 16Apr2021, she felt like throwing up and fainted. Patient also took the covid-19 vaccine and held the medication for two weeks. No further information provided. The action taken in response to the events for tofacitinib citrate was unknown. Outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association,  a contributory role of BNT162B2 vaccine and tofacitinib citrate for syncope cannot be completely excluded. The event seems to be the result of a vagal reaction.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Xeljanz Program from a contactable nurse and a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) 11mg, via an unspecified route of administration from Dec2020 and ongoing (Lot Number: EH9982) at 11 mg for an unspecified indication. Medical history and concomitant medications were not reported. On an unspecified date patient experienced lightheadedness, tired, overheating and breaking out in sweat. On 16Apr2021 she felt like throwing up and fainted. Patient reported experiencing lightheadedness, really tired and felt like overheating and breaking out in sweat. Patient also reported a month and a half before the time of the report, on 16Apr2021, she felt like throwing up and fainted. Patient also took the covid-19 vaccine and held the medication for two weeks. No further information provided. The action taken in response to the events for tofacitinib citrate was unknown. Outcome of the events was unknown.  The information on the batch number has been requested.; Sender's Comments: Assuming a plausible temporal association,  a contributory role of BNT162B2 vaccine and tofacitinib citrate for syncope cannot be completely excluded. The event seems to be the result of a vagal reaction.  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: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Illness, Loss of consciousness, Musculoskeletal discomfort
Clinical narrative: she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown.  Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain).  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown.  Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain).  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Aneurysm ruptured
Clinical narrative: Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery  due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery  due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM.  The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing.  The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm