chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Atrial fibrillation, Blood pressure increased, Blood pressure measurement, Dysgeusia
Clinical narrative: feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). 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. Since the vaccination, the patient has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Malaise, Nausea, Pain in extremity
Clinical narrative: feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). 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. Since the vaccination, the patient has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: feeling a little nauseous; bitter taste back of mouth; felt unwell; sore arm; racing heart; tachycardia; BP 220/110; anxious; a-FIB; crazy heart rate; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in the left arm on 05Mar2021 02:15 AM (lot number EN 6205 (also reported as or ENG205?) as a single dose for COVID-19 immunization. Medical history included high blood pressure 18 yrs, controlled and allergy to cats. Concomitant medication(s) included diltiazem; acetylsalicylic acid (ASPIRIN); magnesium; vitamin B complex (B COMPLEX); and ascorbic acid (C-VITAMIN) (received within 2 weeks of vaccination). 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. Since the vaccination, the patient has not been tested for COVID-19. The shot went fine around 2:00 p.m. that afternoon. On 07Mar2021 12:15 PM, the patient experienced feeling a little nauseous, bitter taste back of mouth, felt unwell, sore arm, racing heart, tachycardia, BP 220/110, anxious, A-Fib, and crazy heart rate. The adverse events resulted in emergency room/department or urgent care (went to ER at 48 hrs after shot) and was hospitalized (admitted) for 2 more days from Mar2021 to Mar2021 (no. of days hospitalization was 2). About four or five hours later feeling a little nauseous, bitter taste back of mouth. Woke 12 hours later, very sore arm. Day 2 just felt unwell, Nausea, taste, day 3 still unwell, breathing, racing heart. BP 220/110, a-FIB, tachycardia, release day five. Day 7 felt normal. Day 9,10 crazy heart rate for a few hours. Day 18 2AM-6AM went into a-FIB. Very anxious now. Day 20 again wake up with Afib /Tachycardia for 2 hours. Scared to get the second shot. The patient heard that he could possibly get the Johnson & Johnson as his number 2. Treatment was received for the adverse events including unspecified medications and liquids. The outcome of the events was recovered with sequelae on Mar2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Confusional state, Dysstasia, Gait disturbance
Clinical narrative: Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Weakness; confusion; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 18Jan2021 at 14:00 (at the age of 77-year-old) as a single dose for COVID-19 immunization. The patient's medical history included AFib, high blood pressure. Concomitant medications included apixaban (ELIQUIS), hydrazaline hydrochloride (APRESOLINE), losartan potassium (COZAAR) and metoprolol; All received within 2 weeks of vaccination. The patient previously took lisinopril and experienced known allergies: Lisinopril. Allergies to medications, food, or other products: Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient been tested for COVID-19 was unknown. The patient did not receive other vaccine in four weeks. Hospitalized on 30Jan2021 for COVID pneumonia which occurred on 24Jan2021 at 08:00 AM and put on ventilator on 05Feb2021. 18 days on ventilator, ICU and released to hospital. On 17Mar2021 admitted to hospital for speech, occupational, and physical therapy. Cannot support standing and walking and vocal cords not fully closed yet on 24Jan2021 at 08:00 AM. Weakness and some confusion on 24Jan2021 at 08:00 AM. The adverse events resulted in emergency room/department or urgent care. The patient was hospitalized for 55 days. The events were considered as serious (hospitalization and disability or permanent damage) by the consumer. The patient was treated with medications and ventilator for the adverse events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vocal cord disorder
Clinical narrative: Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Weakness; confusion; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 18Jan2021 at 14:00 (at the age of 77-year-old) as a single dose for COVID-19 immunization. The patient's medical history included AFib, high blood pressure. Concomitant medications included apixaban (ELIQUIS), hydrazaline hydrochloride (APRESOLINE), losartan potassium (COZAAR) and metoprolol; All received within 2 weeks of vaccination. The patient previously took lisinopril and experienced known allergies: Lisinopril. Allergies to medications, food, or other products: Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient been tested for COVID-19 was unknown. The patient did not receive other vaccine in four weeks. Hospitalized on 30Jan2021 for COVID pneumonia which occurred on 24Jan2021 at 08:00 AM and put on ventilator on 05Feb2021. 18 days on ventilator, ICU and released to hospital. On 17Mar2021 admitted to hospital for speech, occupational, and physical therapy. Cannot support standing and walking and vocal cords not fully closed yet on 24Jan2021 at 08:00 AM. Weakness and some confusion on 24Jan2021 at 08:00 AM. The adverse events resulted in emergency room/department or urgent care. The patient was hospitalized for 55 days. The events were considered as serious (hospitalization and disability or permanent damage) by the consumer. The patient was treated with medications and ventilator for the adverse events. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Malaise, Neck pain, Pain
Clinical narrative: swollen lips and cheeks/Lips got very swollen; swollen lips and cheeks/bottom of cheeks on his face swollen; body aches/Did not feel good all over and was achy; Did not feel good all over and was achy; Neck ache going up to head; Neck ache going up to head; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (reporter's husband) who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EN6205) on 06Mar2021 (at the age of 72-year-old) intramuscularly in arm left at single dose for COVID-19 immunisation. Relevant medical history included arthritis in his neck. Concomitant medications were not reported. The patient experienced not feeling good all over and was achy on 12Mar2021, neck ache going up to head on 12Mar2021, lips got very swollen on 12Mar2021, bottom of cheeks on his face swollen on 12Mar2021. Clinical course was provided as follows. The reporting consumer and her husband both received first dose of vaccine on 06Mar2021. Her husband did not feel good all over and was achy. His neck up to his head was also achy. His lips got very swollen and bottom cheeks of his face were also swollen. They were supposed to go for second shot on Saturday 27Mar2021. Swelling improved within 2 days. They did go through COVID test through this and both tested negative. At first they thought it was the virus. The patient has arthritis in his neck and thought it was a reaction from the vaccine because he was not having any issues before. She thought he was having a stroke. No ER or physician's office was required. On Saturday 13Mar2021, the patient went to his Primary Care physician. No other medical treatment other than taking Pepcid 20mg and Benadryl 25mg 2 tablets orally, both taken from 13Mar2021 to help with symptoms. The events were resolving at the time of report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Swelling face
Clinical narrative: swollen lips and cheeks/Lips got very swollen; swollen lips and cheeks/bottom of cheeks on his face swollen; body aches/Did not feel good all over and was achy; Did not feel good all over and was achy; Neck ache going up to head; Neck ache going up to head; This is a spontaneous report from a contactable consumer. This consumer reported for a 72-year-old male patient (reporter's husband) who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EN6205) on 06Mar2021 (at the age of 72-year-old) intramuscularly in arm left at single dose for COVID-19 immunisation. Relevant medical history included arthritis in his neck. Concomitant medications were not reported. The patient experienced not feeling good all over and was achy on 12Mar2021, neck ache going up to head on 12Mar2021, lips got very swollen on 12Mar2021, bottom of cheeks on his face swollen on 12Mar2021. Clinical course was provided as follows. The reporting consumer and her husband both received first dose of vaccine on 06Mar2021. Her husband did not feel good all over and was achy. His neck up to his head was also achy. His lips got very swollen and bottom cheeks of his face were also swollen. They were supposed to go for second shot on Saturday 27Mar2021. Swelling improved within 2 days. They did go through COVID test through this and both tested negative. At first they thought it was the virus. The patient has arthritis in his neck and thought it was a reaction from the vaccine because he was not having any issues before. She thought he was having a stroke. No ER or physician's office was required. On Saturday 13Mar2021, the patient went to his Primary Care physician. No other medical treatment other than taking Pepcid 20mg and Benadryl 25mg 2 tablets orally, both taken from 13Mar2021 to help with symptoms. The events were resolving at the time of report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: admitted to hospital with covid -19 with symptoms of chills,lethargy,no appetite to eat and trouble breathing; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: UNKNOWN) via an unspecified route of administration on 14Mar2021 (Sunday) at SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021 (Monday) night after the first dose of vaccination patient was having symptoms such as chills, lethargic, and no appetite to eat. Reporter wants to know if these are the normal side effects of the vaccine. On 24Mar2021 (A day before the follow up report), the patient admitted to the hospital with COVID-19. She states she came to hospital yesterday (24Mar2021) because she was still "so lethargic" and reports having trouble in breathing. patient would like to know if it was possible that the Pfizer BioNTech COVID-19 vaccine could have caused her to develop COVID-19. At the time of this report event outcome was unknown.   Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Headache; Low grade temperature; Flu like symptoms achy; Flu like symptoms achy; This is a spontaneous report from a contactable Nurse (Patient herself). A 71-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6207, Expiration Date: Unknown) via intramuscular route of administration in the left arm (Left deltoid) on 18Mar2021 at 15:00 as SINGLE DOSE for COVID-19 Immunization. The patients medical history included ongoing Psoriasis and Psoriatic arthritis from 2008. She had an MI and told her she needed to be on it for a year because of the stent. She has environmental allergies diagnosed 1998. Concomitant medication included Brilinta from 19Oct2021 at 90 mg twice daily as blood thinner. The patient had no family history. The patient had not tested for COVID-19 prior to vaccination and not tested after receiving vaccination. The patient experienced Low grade temperature, Flu like symptoms achy on 24Mar2021 01:00 and Headache on 25Mar2021:07:00 week after receiving the injection. The patient was on a blood thinner because she had a heart attack in Oct 2020. She had first dose a week ago today. She felt fine and had no flu like symptoms. She just had a little soreness. Last night, she had a low grade temperature and feels flu like today and is achy. She checked her temperature this morning. She is normally 97.8 degrees and it was 98.9 degrees. She has psoriatic arthritis and is achy anyway because of that. She has a slight headache when she woke up this morning. She did fine for a week, and through the night, developed these symptoms. No ER or physician's office required. The reporter assessed the events as serious. The outcome of the event headache was not recovered and outcome of all other events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling of body temperature change, Head discomfort, Sluggishness
Clinical narrative: Overnight I felt very cold, chills then very hott.; Overnight I felt very cold, chills then very hott.; weak; heavy; sluggish; This is a spontaneous report from a contactable consumer. A 34-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 02Mar2021 09:30 (Lot Number: Unknown, at the age of 34-years-old) as single dose for covid-19 immunisation. Allergies to medications, food, or other products was none. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in unknown site on an unknown date (Lot Number: Unknown) as single dose for covid-19 immunisation. The patients concomitant medications were not reported. The patient overnight felt very cold, chills then very hot, weak, heavy, sluggish on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19 with symptoms/tested positive for COVID 19/headache and fever; This is a spontaneous report from a contactable healthcare professional (reported for herself; patient). This 52-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 at 08:30 am (age at vaccination was 52 years; Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Patient had no allergies to medications, food, or other products. The patient had no other concomitant medications within two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID prior to vaccination. Patient reported that some days after receiving the vaccine she presented with headache and fever. Start date of adverse events was provided as 17Mar2021 at 4:00 PM. She went to the doctor office/clinic on 21Mar2021 and tested positive for COVID 19 on 22Mar2021 with nasal swab COVID test. Events were treated with ibuprofen and Vitamin C. Her doctor recommended she not receive the second dose for now, which was scheduled on 31Mar2021, and she should wait at least 2 months. Patient was recovering from headache, fever, and tested positive for COVID.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ear discomfort, Heart rate, Oropharyngeal discomfort, Oxygen saturation
Clinical narrative: looked in throat and noted it was red but not swollen; throat felt uncomfortable/throat fells like when she eats olives; ear drums felt pressure; This is a spontaneous report from a contactable nurse. A 28-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK8727 and expiry date was not provided), via intramuscular route, in deltoid left, on 25Mar2021 10:00, as single dose for COVID-19 immunization, at School or Student Health Clinic. Medical history included allergies to Black Olives. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient received the vaccine in her left deltoid, on 25Mar2021 at 10:00 AM. Patient went and sat to wait 15 minutes, when she came back up to the injection station saying her throat felt uncomfortable, and her ear drums felt pressure. Nurse looked in throat and noted it was red but not swollen. SPO2; 98%, HR; 84, BP; 123/64 on 25Mar2021 at 10:17 AM. Patient stated that throat fells like when she eats olives. Patient was given the choose of a friend driving her to an urgent care or we call 911. Patient wanted the friend to drive her to urgent care. Symptoms not getting worse. Left with friend to go to Urgent Care. The patient was the not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Patient had physician office visit for the events. It was unknown treatment received for the adverse event. Outcome of the events was unknown.  Information about batch number and expiration date has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema
Clinical narrative: looked in throat and noted it was red but not swollen; throat felt uncomfortable/throat fells like when she eats olives; ear drums felt pressure; This is a spontaneous report from a contactable nurse. A 28-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK8727 and expiry date was not provided), via intramuscular route, in deltoid left, on 25Mar2021 10:00, as single dose for COVID-19 immunization, at School or Student Health Clinic. Medical history included allergies to Black Olives. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient received the vaccine in her left deltoid, on 25Mar2021 at 10:00 AM. Patient went and sat to wait 15 minutes, when she came back up to the injection station saying her throat felt uncomfortable, and her ear drums felt pressure. Nurse looked in throat and noted it was red but not swollen. SPO2; 98%, HR; 84, BP; 123/64 on 25Mar2021 at 10:17 AM. Patient stated that throat fells like when she eats olives. Patient was given the choose of a friend driving her to an urgent care or we call 911. Patient wanted the friend to drive her to urgent care. Symptoms not getting worse. Left with friend to go to Urgent Care. The patient was the not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. Patient had physician office visit for the events. It was unknown treatment received for the adverse event. Outcome of the events was unknown.  Information about batch number and expiration date has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Throat irritation
Clinical narrative: Throat got itchy; Pain in arm; Arm burned; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient reported for herself that she received received second dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6199, Expiration date: unknown) via an unspecified route of administration on 12Mar2021 on right arm at single dose for COVID-19 Immunization. Medical history included Asthma, sleep apnea, autoimmune and had allergies to medications, food, Tetneus shot, milk and erythromycin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) on 19Feb2021 at 12:30 for covid-19 immunisation. The concomitant medication included Claritin. 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 19Mar2021 2:30, (two hours after second dose vaccination), patient experienced throat got itchy, and it lasted for a few hours, no breathing issue was reported just slightly itchy throat and pain in arm. Patient also had arm burned right after shot. Patient did not received any treatment for the events. The events were recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: weird dreams; slight dizziness; headache; nausea; fatigue; difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613) at right arm, via an unspecified route of administration at left arm on 22Mar2021 14:30 (at the age of 65-year-old) at single dose for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included depression, anxiety and hypothyroid. No known allergies reported. Concomitant medications included Synthroid and Estradiol. On 23Mar2021 12:00, day after starting the therapy, the patient experienced headache, nausea, fatigue, difficulty sleeping, on 25Mar2021 third day after the vaccination slight dizziness and weird dreams. The patient not received treatment for the adverse events. No covid tested post vaccination. The patient had no covid prior vaccination. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID19, Since the vaccination. Seriousness as reported non-serious. The outcome of events was not recovered.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: weird dreams; slight dizziness; headache; nausea; fatigue; difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613) at right arm, via an unspecified route of administration at left arm on 22Mar2021 14:30 (at the age of 65-year-old) at single dose for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included depression, anxiety and hypothyroid. No known allergies reported. Concomitant medications included Synthroid and Estradiol. On 23Mar2021 12:00, day after starting the therapy, the patient experienced headache, nausea, fatigue, difficulty sleeping, on 25Mar2021 third day after the vaccination slight dizziness and weird dreams. The patient not received treatment for the adverse events. No covid tested post vaccination. The patient had no covid prior vaccination. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID19, Since the vaccination. Seriousness as reported non-serious. The outcome of events was not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral
Clinical narrative: drooping face on tight side, diagnosed as Bell's Palsy in the ER; Numbness of lips; This is a spontaneous report received from a contactable other non-Health Care Professional (Patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: En6201 and expiry date was not provided), via an unspecified route of administration, in Arm left, on 12-MAR-2021 10:45 AM (at the age of A 64-year-old) as a single dose for COVID-19 immunization. Medical history included Diabetes, high blood pressure and Allergies to medications, food, or other products Tetanus Shot. Concomitant medications received within 2 weeks of vaccination were Magnesium 500mg, Lisinopril 20mg, Chlorthalid 25mg. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that numbness of lips, drooping face on tight side. Diagnosed as Bells Palsy in the ER. CAT scan to rule out other causes on 19Mar2021. Patient went to Emergency room/department or urgent care, where the patient put on Prednisone for 5 days and anti-viral for 7 days for the adverse events. Outcome of the events was Not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Nausea
Clinical narrative: slight shortness of breath from 1500-1530; Nausea; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:15 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included Hashimotos, HBP and Known allergies to latex, nickel, some fragrances. Concomitant medication(s) included valsartan (VALSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Since 24Mar2021 13:15, the patient experienced Dizziness and Nausea and slight shortness of breath from 1500-1530. The events were assessed as non-serious. No treatment received for the adverse event. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: little bit of rash on the chest and stomach area; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that Patient experienced little bit of rash on the chest and stomach area and it's now fading away. She wants to know if this is normal side effect of the vaccine and if she can have the 2nd dose. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Sinus rhythm
Clinical narrative: I developed weak, rapid, irregular heartbeat indicative of atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: ER2613) via an unspecified route of administration in left arm on 19Mar2021 at 11:00 am (at the age of 64-year-old) for COVID-19 immunisation. Medical history included persistent atrial fibrillation, allergies to sulfa. Patient was not pregnant at the time of vaccination. Heart in regular sinus rhythm for several months prior to vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included dofetilide (TIKOSYN) 250mcgtwice daily, loratadine and ibuprofen, (all received within 2 weeks of vaccination). The patient previously took dofetilide (TIKOSYN) for atrial fibrillation (persistent atrial fibrillation was controlled with 250mcg twice daily); also took erythromycin and had allergies. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 17:15, the patient developed weak, rapid, irregular heartbeat indicative of atrial fibrillation. This last 8 hours. The patient did not receive any treatment for the events. Patient noted regular heartbeat on 21Mar2021 at 1:15am. Patient visited to physician office for events. The outcome for the event was recovered on 21Mar2021 at 1:15am.  Follow up attempts needed. Further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Anxiety, Arthralgia, Back pain, Blood test
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cough, Diarrhoea
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Faeces soft, Fatigue, Headache
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Increased upper airway secretion, Insomnia, Myalgia, Nausea
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sneezing, Vaccination site pain
Clinical narrative: Growing anxiety; Injection site pain; Muscle & joint pain; Muscle & joint pain; Tiredness; Headache; Coughing; Sneezing; Copious amount of mucous from nose/throat; Copious amount of mucous from nose/throat; Nausea; Vomiting; Diarrhea; Chills; Lightheaded/dizzy; Fever (99.1-99.3F); Sweating; Chest pressure; Back pain on left side from waist to neck; Difficulty breathing; Severe insomnia; Soft stools with loss of bowel control; Soft stools with loss of bowel control; This is a spontaneous report from a Non-contactable consumer (herself reporting). This 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Not reported) via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. The patient was allergic to mycin,neosporin/bacitracin. The patient's medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior vaccination. After 24 to 48 hours of vaccination the patient experienced injection site pain spread to whole-body muscle & joint pain, tiredness, headache, coughing, sneezing, copious amount of mucous from nose/throat, nausea, vomiting, diarrhea, lightheaded/dizzy, chills/fever (99.1-99.3F)/sweating, chest pressure and back pain on left side from waist to neck, difficulty breathing, severe insomnia. After 48 to 72 hours of vaccination the patient experienced Soft stools with loss of bowel control. Growing anxiety due to chest pressure and back pain on left side from waist to neck, difficulty breathing and severe insomnia and all the above events except coughing, sneezing, mucous, vomiting and diarrhea and the patient was sent to emergency room/department or urgent care and hospitalized for one day. The patient received IV, EKG (electrocardiogram), blood panels, X-ray, Ibuprofen, Ativan (lorazepam) as treatment for the events. The patient underwent unknown COVID test post vaccination in ER (emergency room) which shown negative result. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.