chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Feeling abnormal, Feeling hot, Hot flush
Clinical narrative: fuzzy; confused; got really hot; dizzy; flash of heat; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) intramuscular in the right arm on 10Mar2021 (time the vaccination was given: 08:45-09:00) at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient had no family medical history. There were no additional vaccines administered on same date of the Pfizer suspect. No previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks. Adverse event (AE) following prior vaccinations were noted as none (never had a reaction to a vaccine before). It was reported that the patient would like to know if she should receive her second dose of the Pfizer BioNTech COVID-19 vaccine based on the side effects she experienced after receiving her first dose yesterday. She already has an appointment scheduled for second dose. She waited in store 10 minutes after receiving it and felt fine. On the drive home, she felt a little fuzzy or confused and then got really hot and felt a little dizzy, but that went away within 15 minutes. It was further stated that within 15 minutes of getting the vaccine on 10Mar2021, she "got kind of fuzzy" (felt fuzzy) and first confused 09:10, then felt hot and then dizzy 09:15; these events were assessed as serious medically significant. Additionally, she experienced a "flash of heat that went through her body" on 10Mar2021 which went away within 10 minutes. No ER or physician's office required.  She felt like if she just got some water, she would be fine. No test was done. The feeling of confusion was what lasted the most and the dizziness did not last very long. The outcome of the events was recovered on 10Mar2021. The events felt fuzzy, confused, hot and dizzy was related to BNT162B2 per reporter.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events fuzzy, confused, feeling hot and dizzy. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has been a little sore; cough; feel like allergies all flared environmental and food; nausea; felt horrible; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ENG199), via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, vestibular migraines, allergies to all tree nuts, sunflower oil 25 very high, milk and egg whites, environmental allergy, the patient was recently vegan due to an anaphylactic attack. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydroxychloroquine, varenicline tartrate (CHANTIX), escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), metronidazole (TRIAM). There was no other vaccine administered within 4 weeks of the vaccination. On 05Mar2021 at 00:00, the patient woke up feeling like she had the flu. She had trouble breathing and felt like she had a chest cold. She felt fatigue and horrible. This reminded her of how she felt when she had strep throat. Her throat had been a little sore, she had a cough and nausea. She also felt like her environmental and food allergies flared. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "feel like I have a chest cold", "feeling like I had the flu", trouble breathing, fatigue, throat has been a little sore, cough, "feel like allergies all flared environmental and food", nausea and felt horrible was resolving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lower respiratory tract infection, Nausea, Oropharyngeal pain
Clinical narrative: feel like I have a chest cold.; feeling like I had the flu; trouble breathing; fatigue; throat has been a little sore; cough; feel like allergies all flared environmental and food; nausea; felt horrible; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ENG199), via an unspecified route of administration in the left arm on 04Mar2021 at 17:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis, vestibular migraines, allergies to all tree nuts, sunflower oil 25 very high, milk and egg whites, environmental allergy, the patient was recently vegan due to an anaphylactic attack. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydroxychloroquine, varenicline tartrate (CHANTIX), escitalopram oxalate (LEXAPRO), lisdexamfetamine mesilate (VYVANSE), metronidazole (TRIAM). There was no other vaccine administered within 4 weeks of the vaccination. On 05Mar2021 at 00:00, the patient woke up feeling like she had the flu. She had trouble breathing and felt like she had a chest cold. She felt fatigue and horrible. This reminded her of how she felt when she had strep throat. Her throat had been a little sore, she had a cough and nausea. She also felt like her environmental and food allergies flared. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "feel like I have a chest cold", "feeling like I had the flu", trouble breathing, fatigue, throat has been a little sore, cough, "feel like allergies all flared environmental and food", nausea and felt horrible was resolving.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Meniere's disease, Vision blurred
Clinical narrative: Meniere flare-up for 24 hours; Blurry vision; This is a spontaneous report from a contactable consumer (patient).   A 64-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 09Mar2021 at 09:00 AM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy to Brazil nuts, buckwheat and shrimp. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3) and iron, all received from an unspecified date (within 2 weeks), at an unknown dose, for an unspecified indication. On 10Mar2021, the patient experienced blurry vision and Meniere flare-up for 24 hours. No treatment was received. The patient recovered from the events on 11Mar2021. Post the vaccination, the patient has not been tested for COVID-19.  The information on the Lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear discomfort, Gait disturbance, Jaw clicking, Neck pain
Clinical narrative: neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned  these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient).  This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned  these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient).  This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, Pyrexia
Clinical narrative: Prolonged fever, leukocytosis; Prolonged fever, leukocytosis; This is a spontaneous report from a contactable physician.   An adult male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced prolonged fever, leukocytosis on Feb2021 with outcome of unknown.  The patient was hospitalized for prolonged fever and, leukocytosis for 7 days.  Treatment was unknown.  It was unknown if patient had COVID prior vaccination or if patient was COVID tested post vaccination.   Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  fever and leukocytosis  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including blood cultures and chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Sudden onset of Atrial Fibrillation within 2 minutes; This is a spontaneous report from a contactable physician (patient). This 81-years-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6206, on 05Mar2021 10:45 in right arm as a single dose (at the age of 81 years) for COVID-19 immunization.  The patient had dose 1 of BNT162B2 for COVID-19 immunization, Lot number EL9261, on 05Feb2021 10:45, in Left arm.  Relevant medical history included GERD (gastrooesophageal reflux disease).  There were no allergies reported. Concomitant medication included Omeprazole, Ursodiol, fexofenadine hydrochloride (Allegra), diphenhydramine hydrochloride (Benadryl).  The patient had no other vaccine in four weeks.  The patient experienced sudden onset of Atrial Fibrillation within approximately 2 minutes on 05Mar2021 reported as 10:45. The patient was seen at the physician's office.  Treatment included EKG; Xeralto anticoagulant.  The patient did not have COVID prior to vaccination and was not tested post vaccination.  The outcome of sudden onset of Atrial Fibrillation was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pneumonia
Clinical narrative: pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 76-year-old, on Jan2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was due to get the second dose on 18Feb2021 but was in the hospital with pneumonia and was unable to get the second dose. She is coming up on 60 days now.  Outcome was unknown.  Information about lot/ batch number has been requested
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in left hand (pinky and ring finger)/Neuropathy consists of numbness and parasthesias; This is a spontaneous report from a contactable pharmacist (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-year-old, via an unspecified route of administration, administered in left arm (reported also as left shoulder) on 08Mar2021 12:45 (Lot Number: EN6199) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 11Mar2021 (reported as 3 days after the vaccination), the patient experienced neuropathy in left hand (pinky and ring finger) which consists of numbness and parasthesias. The patient took aspirin with no effect. As of 11Mar2021, the event was not recovered.; Sender's Comments: The information is limited and does not allow a full medical assessment. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of neuropathy, cannot be excluded. The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea
Clinical narrative: She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via unspecified route of administration on 01Mar2021 at 14:00 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient called to report that her second dose is due on 25Mar2021 (24 days after the first dose) and wanted to know if this is ok to do. She stated that she had 20 hours of diarrhea yesterday (10Mar2021) and today (11Mar2021), she has not had a bowel movement. The events did not result to emergency room/ physician clinic visit. The outcome of the event 20 hours of diarrhea was recovered on 11Mar2021 while the other event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity vasculitis
Clinical narrative: allergic vasculitis; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age (Age: 66; unit: unknown) received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. It was reported that the patient had one dose of the pfizer covid 19 vaccine and had a body rash that was diagnosed as allergic vasculitis. The patient had been advised to not get the second dose. The patient wanted an opinion on getting the second dose and wanted to know how long the side effect might last and are there long term effects. The patient also asked if he can take the Johnson and Johnson vaccine after having taken the Pfizer covid 19 vaccine, is there an interaction between the vaccines and if after having one dose of the vaccine, what coverage does he have. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dyspnoea, Palpitations, Syncope
Clinical narrative: Brief loss of vision; Faint; Short of breath; Palpitations; This is a spontaneous report from a contactable other health professional. A 22-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), intramuscular in arm left, on 11Mar2021 at 13:00 (Lot Number EN6207), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced brief loss of vision (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, faint (medically significant) on 11Mar2021 at 13:00 with outcome of unknown, short of breath (non-serious) on 11Mar2021 at 13:00 with outcome of unknown, palpitations (non-serious) on 11Mar2021 at 13:00 with outcome of unknown. Therapeutic measures were taken as a result of the events. It was reported that the events were evaluated and advanced life support (ALS) transported the patient to the emergency department (ED). It was unknown if patient was tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The possibility that suspect drug may have contributed to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Vaccination site pain
Clinical narrative: Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 51-year-old, administered in Arm Right on 01Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced arm soreness in Mar2021 (after vaccination). The patient experienced bell's palsy/experienced no mobility in the left side of the face and was diagnosed with bells palsy on 08Mar2021. The patient went to the ER in response to bell's palsy. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: paralysed for 10 hours, in both arms and legs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient took both doses of the Pfizer covid vaccine, but after the second dose he was paralysed for 10 hours, in both arms and legs on an unspecified date. Outcome of the event was recovered on an unspecified date.    Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Muscular weakness, Paralysis
Clinical narrative: paralysed for 10 hours, in both arms and legs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient took both doses of the Pfizer covid vaccine, but after the second dose he was paralysed for 10 hours, in both arms and legs on an unspecified date. Outcome of the event was recovered on an unspecified date.    Information about lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: I discovered bleeding like bruise; I discovered bleeding like bruise; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient reported "I discovered bleeding like bruise in about 1 X 1 inches on my right fore arm" on 04Mar2021 at 14:30. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, Vomiting
Clinical narrative: Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, first dose) solution for injection intramuscular in the right arm on 03Mar2021 at 15:45 (at the age of 20-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included bupropion. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 10:00, the patient experienced extreme morning sickness and vomiting. Started on 08Mar2021, has continued persistently since. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization in Mar2021 for 1 day. Lab test on 08Mar2021 included Nasal Swab SARS-COV-2 PCR was negative. Treatment for the events morning sickness and vomiting included IV fluids, prochlorperazine, diphenhydramine. The outcome of the events morning sickness and vomiting was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute hepatic failure, Jaundice, Malaise
Clinical narrative: symptoms of liver failure. Liver seems to be shutting down.; began to feel ill, illness continued over time; Jaundice; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 68-years-old via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date for covid-19 immunisation. It was reported that within 24hrs of receiving the vaccine on 20Feb2021, the patient began to feel ill, illness continued over time, eventually when to doctor and presented symptoms of liver failure. Liver seems to be shutting down. Jaundice has set in over the past 5 days. It was unknown if the patient received any treatment for the events. The patient did not recover from the events.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: I went to hospital on 04Feb2021 and was diagnosed with TIA.; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation (Afib), high blood pressure, pacemaker, type 2 diabetes and high cholesterol. Concomitant medications included apixaban (ELIQUIS), metformin (METFORMIN), levothyroxine sodium (SYNTHROID) and valsartan (VALSARTAN). The patient reported "I went to hospital on 04feb2021 and was diagnosed with tia. (transient ischaemic attack)" on 04Feb2021. The patient was hospitalized for the event from 04Feb2021 to an unknown date. The patient received first dose of BNT162B2 on 14Jan2021 First dose (lot number EL3248, vaccine location= Left arm). Therapeutic measures were taken which was reported as AE treatment Jardiance. Outcome of the event was recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - 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, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nausea, Retching, Seizure
Clinical narrative: mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - 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, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Vaccination site pain, Vital signs measurement
Clinical narrative: mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - 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, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis
Clinical narrative: throwing blood clots within a few weeks of final vaccine.; This is a spontaneous report from a contactable consumer (patient's daughter) via a Pfizer-sales representative. A male patient of an unspecified age received the second dose (reported as final dose - pending clarification) of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. Medical history included history of blood clots and transient ischemic attacks (TIAs). The patient's 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, the patient experienced throwing blood clots within a few weeks of final vaccine. The patient and the daughter are concerned about the vaccine having this effect. The outcome of the event was unknown.  Information about the batch/lot number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Gastrointestinal haemorrhage, Haematemesis, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever and was hospitalized with gastrointestinal bleeding.; fever and was hospitalized with gastrointestinal bleeding.; abdominal pain; vomiting with blood; This is a spontaneous report from a non-contactable consumer. A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot: unknown), via an unspecified route of administration on 26Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient's medical history was not reported. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) taken for a year. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot: unknown) on 05Feb2021 for COVID-19 immunisation. On 09Mar2021, the patient experienced fever and was hospitalized with gastrointestinal bleeding, abdominal pain, and vomiting with blood. The events caused hospitalization on an unspecified date. It was reported that patient had COVID test post vaccination on 10Mar2021 with unknown results. Therapeutic measures were taken as a result of all events. The outcome of all events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Dizziness, Heart rate, Pain
Clinical narrative: diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Blood glucose, Blood triglycerides, Investigation
Clinical narrative: it is still affecting him (Bell's palsy), his lip is still paralyzed; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided, expiration date: Jun2021) at the age of 66-years-old, via an unspecified route of administration on 27Feb2021 at 14:00 at single dose for COVID-19 immunization. Medical history included diabetes, high triglycerides, and allergy to beef product. Concomitant medication included lisinopril and ongoing unspecified medications. He did not have any other vaccines within four weeks prior to the COVID vaccine. The patient was administered with COVID vaccine in a pharmacy or drug store. The reporter stated that they read quite a bit about Bell's palsy affecting some people after the second COVID shot but the patient experienced Bell's palsy after his first COVID shot on 04Mar2021 at 06:00 and it was still affecting him, his lip was still paralyzed. This required a physician office visit and the patient was treated with an antiviral drug that did not work therefore he was prescribed prednisone on 14Mar2021. He is supposed to get his second COVID shot on Saturday, they were concerned as far as to whether it was safe for him to get the other shot. The patient underwent lab tests and procedures which included triglycerides which were high on an unspecified date; and blood sugar on an unspecified date and blood work for diabetes on 03Mar2021, both with unknown results. The outcome of the event was not recovered.   Information about lot/batch number has been requested
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Insomnia, Myocardial infarction, Pain in extremity
Clinical narrative: I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Investigation
Clinical narrative: cardiac arrhythmia; Atrial fibrillation; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EL8932), via an unspecified route of administration, administered in the left arm on 21Jan2021 as a single dose for covid-19 immunization. The patient's medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing , Defibrillator/pacemaker insertion from 2015 to an unknown date. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The next day after 1st dose the patient experienced a 7hr period of atrial fibrillation (all recorded on a cardiac monitor), he stated he was dizzy, light headedness and periods of shortness of breath. He just became aware of this cardiac arrhythmia from his Cardiologist. He has an internal heart monitor and the Doctor was able to see this report. He was now taking medication for A-FIB. It was reported that patient never had it until the night he got the shot. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Atypical pneumonia, Lung neoplasm malignant, Pyrexia
Clinical narrative: possible diagnosis of lung cancer or walking pneumonia; possible diagnosis of lung cancer or walking pneumonia; she had a high temperature; This is a follow up spontaneous report. This is a report from a contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown, on 18Feb2021 via unspecified route as a single dose for COVID-19 immunization.  Relevant history and concomitant medications were not reported.  Following first dose and on an unspecified date the patient got a possible diagnosis of lung cancer or walking pneumonia. Her doctor advised her to cancel her appointment for her second dose and reschedule it for later, she had a high temperature and she missed her 2nd dose of the vaccine. She wants to reschedule the 2nd dose of her vaccine.  Patient declined to confirm contact information or provide address, or email and wanted to only reschedule her second appointment.  Outcome of event possible diagnosis of lung cancer or walking pneumonia and high temperature was unknown.    Information about lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Palpitations
Clinical narrative: Heart arrhythmia and palpitations 96 hrs post-vaccine; Heart arrhythmia and palpitations 96 hrs post-vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. Medical history of the patient was reported as none. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 09:00 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunization. On 14Feb2021 14:00 patient experienced heart arrhythmia and palpitations 96 hrs post-vaccine. Treatment included EKG, cardio. Consult, Holter Monitor, stress test. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. Patient did not had COVID prior vaccination and didn't tested covid post vaccination. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected