chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Head discomfort, SARS-CoV-2 test, Thinking abnormal
Clinical narrative: fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dysstasia, Gait inability
Clinical narrative: unable to get up, stand or walk; unable to get up, stand or walk; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient.   An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EN5318 and expiry date unknown) on 06Feb2021 13:30 at single does via an unspecified route of administration into her right arm for COVID-19 immunization.  Medical history included asthma, chronic obstructive pulmonary disease (COPD), osteoarthritis, marginal zone lymphoma (stable not treated at this time), prior ductal carcinoma in situ (DCIS). Known allergies: Sulfa Drugs, Macrobid. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination.  Concomitant medications in two weeks: fluticasone propionate/salmeterol xinafoate (ADVAIR), ipratropium bromide/salbutamol sulfate (COMBIVENT), losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), meloxicam (MELOXICAM), tamoxifen (TAMOXIFEN), acetylsalicylic acid (ASPIRIN) low dose, ascorbic acid/biotin/ calcium/calcium phosphate dibasic/chromic chloride/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium oxide/manganese sulfate/nickel sulfate/nicotinamide/pantothenic acid/ phytomenadione/ potassium chloride/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/sodium metasilicate/sodium molybdate/ sodium selenate/hiamine mononitrate/ tocopheryl acetate/vitamin d nos/zinc oxide (CENTRUM SILVER), ascorbic acid (VITAMIN C). No other vaccine received in four weeks.  On 06Feb2021 at 19:00, approximately 5.5 hours after the vaccination, the patient sat down and was unable to get up, stand or walk, was leaning to side in chair, which lasted for at least 1.5 - 2 hours. The events resulted in emergency room/department or urgent care and hospitalization for 1 day. Bloodwork and CT scan were done; the patient was observed overnight. The event was resolved on an unspecified date in Feb2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: Noticed light spotting; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number E19769 and expiry date unknown) on 06Feb2021 15:30 at single dose via an unspecified route of administration into her left arm for COVID-19 immunization. There were relevant medical history and no concomitant medications. The patient had not had COVID prior to the vaccination, COVID not tested post the vaccination. The patient was not pregnant. She noticed light spotting on 07Feb2021 at 21:45. No seriousness criterion provided. No treatment was received. The outcome of event was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus, Vaccination site discomfort
Clinical narrative: Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered "Big echo on right ear" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported "related".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2;  the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product.  The impacts 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort
Clinical narrative: anaphylactic reaction; Chest tightness; This is a spontaneous report from a contactable consumer. A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on 30Jan2021 09:30 at single dose for covid-19 immunisation.  Medical history included severe peanut allergy.  Concomitant medication included diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), both for severe peanut allergy.  She went to the Emergency Room after having an anaphylactic reaction on 31Jan2021.  She was in the emergency room for four hours. She has taken Solu-Medrol and Benadryl. She has a severe peanut allergy that she had this medication for it. The anaphylactic reaction last for 24 hours. She also experienced chest tightness on 31Jan2021 that continued. She was given Epinephrine, Solu-Medrol and Benadryl in the ambulance. Therapeutic measures were taken as a result of anaphylactic reaction and chest tightness. The outcome of anaphylactic reaction was recovered on 31Jan2021, for chest tightness was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Syncope
Clinical narrative: The man walked approximately 30 feet and collapsed/fainted; Extremely diaphoretic; This is a spontaneous report from a non-contactable consumer (volunteer at a vaccination clinic) reporting for a patient. A male adult in his 30's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date unknown) via an unspecified route of administration on 07Feb2021 around 15:00 at a single dose for COVID-19 immunization. No information about the patient's medical history and concomitant drugs was provided. After receiving the vaccine, the man walked approximately 30 feet and collapsed. The onsite supervisor from the institute indicated that he was extremely diaphoretic and had "fainted" before he could reach the post-vaccination observation area. EMS (Emergency Medical Services) was stationed onsite and assisted the man. The man was placed in a chair for approximately 15 minutes. An electrocardiogram (ECG) appeared to have been performed. The man was then transported to the hospital for further evaluation of concussion as it was believed that his head might have impacted a table and/or the floor when he collapsed. It was not specified if the patient was admitted to the hospital. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (age at vaccination: 48 years old) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EKS730; Expiration date was not reported), intramuscularly on the left deltoid on 06Jan2021 (17:00) at a single dose for COVID-19 immunization in the hospital (not a military facility). Medical history obesity, osteoarthritis and low vitamin D level. Concomitant medication included ibuprofen from 18Dec2021 to an unspecified date. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EKS730; Expiration date was not reported) on 18Dec2020 (when the patient was 47 years old) for COVID-19 immunization, and had numbness and tingling on the left arm to fingers. In Jan2021, the patient had muscle soreness and fatigue. The outcome of the events, muscle soreness and fatigue, was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: diarrhea; vomiting; fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 25Jan2021 at 09:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history and concomitant medications were not provided. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:00 AM via an unspecified route of administration in Left arm for COVID-19 immunisation, lot number: EK4176. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 07Feb2021 at 12:30 AM patient experienced diarrhea, vomiting and fever. No treatment received for the events. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the events at the time of the report.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Syncope
Clinical narrative: fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in her leg; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age (reported only as 72) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient believed she may have a blood clot in her leg since an unspecified date. She had the second vaccine dose scheduled on an unknown date. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Meningitis viral, Pyrexia
Clinical narrative: hospitalized with viral meningitis; Headaches; fever; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 24Jan2021 at 12:15 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient experienced headaches and fever on 26Jan2021. The patient experienced viral meningitis on 01Feb2021 and was hospitalized with viral meningitis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received for the adverse events. The no days of hospitalization was 8. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Irregular breathing, Loss of consciousness, Nausea, Snoring, Staring
Clinical narrative: Unresponsive to stimuli; Loss of consciousness; Irregular breathing; Nausea; Snoring; Staring; This is a spontaneous report from a non contactable  consumer.  A 46-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 28Dec2020 at single dose  for Covid-19 immunisation. Medical history included exercise induced asthma, penicillin hypersensitivity. Previously the patient received flu vaccine and TDAP vaccine  and experienced nausea and body aches about 2010.   The patient's concomitant medications were not reported.  The patient was unresponsive to stimuli  on 29Dec2020 with outcome of recovered , experienced  loss of consciousness on 29Dec2020 with outcome of recovered , had irregular breathing on 29Dec2020 with outcome of recovered , nausea  on 29Dec2020 with outcome of recovered , snoring on 29Dec2020 with outcome of recovered , staring  on 29Dec2020 with outcome of recovered.   The events loss of consciousness and unresponsive to stimuli were considered Important Medical Events.  It was reported that the patient  woke up in the night, walked downstairs to get water, walked back upstairs and became nauseous, laid down and became unresponsive. Eyes were open but not focused, breathing was irregular and snoring-like. This lasted less than a minute and he regained consciousness.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli; Loss of consciousness; Irregular breathing; Nausea; Snoring; Staring; This is a spontaneous report from a non contactable  consumer.  A 46-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EK9231) vaccine , intramuscular in the left arm on 28Dec2020 at single dose  for Covid-19 immunisation. Medical history included exercise induced asthma, penicillin hypersensitivity. Previously the patient received flu vaccine and TDAP vaccine  and experienced nausea and body aches about 2010.   The patient's concomitant medications were not reported.  The patient was unresponsive to stimuli  on 29Dec2020 with outcome of recovered , experienced  loss of consciousness on 29Dec2020 with outcome of recovered , had irregular breathing on 29Dec2020 with outcome of recovered , nausea  on 29Dec2020 with outcome of recovered , snoring on 29Dec2020 with outcome of recovered , staring  on 29Dec2020 with outcome of recovered.   The events loss of consciousness and unresponsive to stimuli were considered Important Medical Events.  It was reported that the patient  woke up in the night, walked downstairs to get water, walked back upstairs and became nauseous, laid down and became unresponsive. Eyes were open but not focused, breathing was irregular and snoring-like. This lasted less than a minute and he regained consciousness.  No follow up attempts are possible. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Immune thrombocytopenia
Clinical narrative: Drop in hemoglobin level; Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension and other unspecified conditions. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant included unspecified multiple medications. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient experienced drop in hemoglobin level resulting in idiopathic thrombocytopenic purpura (ITP) on 04Feb2021 with outcome of not recovered. The event resulted in physician office visit and emergency room visit. Patient had no history of ITP prior to vaccination. The event was considered serious as caused patient's hospitalization and as life threatening. The patient underwent lab tests and procedures which included hemoglobin: drop on 04Feb2021. Therapeutic measures were taken as a result of the event and included treatment with multiple unspecified drugs. It was unknown if she was tested for COVID-19 after vaccination.  The information on the lot/batch number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: He was bleeding, it came out from his rectum through feces; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included gout. Concomitant medications included colchicine for gout and a lot of unspecified medications. The patient took a COVID vaccine yesterday and this morning he was bleeding through the 'raw', it came out from his rectum through feces on 07Feb2021. He stated that the next shot was between 27Feb and 19Mar (Clarification unknown). So it was one day between those two days. He said he still was just a little bit, not like he was. No treatment was received for the event. The outcome of the event was recovering.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: severe pains right underneath her breasts; like a huge belt was tightening and tightening; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: PFREL1283, expiry: 30Apr2021) intramusculary into the right arm on 15Jan2021 15:30 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 16Jan2021 04:00, patient started to get severe pains right underneath her breasts, it was like a huge belt was tightening and tightening. Patient thought maybe she was getting a heart attack. It was further reported that at 06:30, it stopped and she has been fine ever since. The patient did not require an emergency room or physician office visit. Outcome of events recovered on 16Jan2021 06:30.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Hyperventilation, Panic attack
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 34-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3247) at right arm on 04Feb2021 at single dose for Covid-19 immunization. The patient received her first shot (lot number EL3247) at right arm on 04Jan2021. Patient's medical history included acid reflux. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Anxiety started three days after receiving the second shot (07Feb2021). Patient was shortness of breath. The patient had emergency room/department or urgent care and visited doctor or other healthcare professional office/clinic visit. Per ER, she was hyperventilating which caused her to have panic attacks. Patient had medication for anxiety. Outcome of the events was resolving at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: diagnosed with cellulitis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported for husband that a male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diagnosed with cellulitis and in hospitalization on an unspecified date with outcome of unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure increased, Blood pressure measurement, Body temperature, Body temperature increased
Clinical narrative: He did have a slight A fib condition; his blood pressure went 189; his temperature was 103; He was really sick; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for her brother. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The day after his vaccine, his blood pressure went 189/ over something, and his temperature was 103. He was really sick. He did have a slight A fib condition. Outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093425 Same reporter/ vaccine, different patient and events.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: He did have a slight A fib condition; his blood pressure went 189; his temperature was 103; He was really sick; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer who reported for her brother. A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The day after his vaccine, his blood pressure went 189/ over something, and his temperature was 103. He was really sick. He did have a slight A fib condition. Outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093425 Same reporter/ vaccine, different patient and events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Body temperature, Computerised tomogram head, Dizziness, Facial paralysis
Clinical narrative: Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging, Myalgia, Neuralgia, Occipital neuralgia
Clinical narrative: Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Butterfly rash, Chest pain, Ear pain, Eye pain
Clinical narrative: Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021.  The outcome of events was recovering.  Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Headache, Hyperhidrosis, Pain
Clinical narrative: Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021.  The outcome of events was recovering.  Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pruritus, Pyrexia, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: Severe Headache; eye pain; earache on side of shot; itching both arms; severe jaw pain; severe chest pain; body ache; high fever; fatigue; profuse sweating; belabored breathing; hot; butterfly rash of face; This is a spontaneous report from a contactable physician (patient). A 66-year-old female (Not pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at right arm on 11Feb2021 14:30 at single dose for covid-19 immunization. Medical history included hypothyroidism, hypertension, hypercholesterolemia, breast cancer, osteoporosis, ligamentous RA, degenerative joint disease (DJD). The patient had known allergies to cilantro, cephalosporins, all morphine and morphine derivatives, Herceptin, astralogous mushrooms, gadolinium dye, fentanyl. The patient's concomitant medications reported as other medications in two weeks was yes.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe headache, eye pain, earache on side of shot, itching both arms, severe jaw pain, severe chest pain, body ache and high fever &fatigue - profuse sweating, belabored breathing hot butterfly rash of face on 12Feb2021 at time of 06:00 AM. AEs resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient received Prednisone 80 mg and Benadryl 50 mg as treatment. Prior to vaccination, the patient was diagnosed with COVID-19. Covid was tested post vaccination. The patient underwent lab tests and procedures which included Nasal Swab and PCR test: negative on 09Feb2021.  The outcome of events was recovering.  Information on Lot/Batch has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Death, Off label use
Clinical narrative: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.; a young premature baby received BNT162B2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patients. This is 1st of 2 reports.  A patient of unspecified age and gender (reported as a young premature baby) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated his main concern was even though the vaccine had been authorized. The vaccine was only given vaccine on the side of the road. People were dying from the vaccine more than from the virus. He gave out some percentage of people that could die from the virus vs from the vaccine. The percentage of death rate was 0.00045% from the virus. The percentage of death from the vaccine was 6.6%. There were many people reporting side effects such as bell's palsy, whole body convulsion. Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who died 15 minutes after receiving the vaccine. He said it's sad these were front line worker who were facing all these side effects. The outcome of the event was fatal.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157531 same reporter, drug, event, different patient; Reported Cause(s) of Death: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Paraesthesia
Clinical narrative: tingling sensation; lightheadedness; This is a spontaneous report from a contactable consumer via a Pfizer Sales Representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced tingling sensation and light-headedness post vaccination. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar event for 2 patients. This is 2nd of 2 reports.  A 25-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The consumer stated his main concern was even though the vaccine had been authorized. The vaccine was only given vaccine on the side of the road. People were dying from the vaccine more than from the virus. He gave out some percentage of people that could die from the virus vs from the vaccine. The percentage of death rate was 0.00045% from the virus. The percentage of death from the vaccine was 6.6%. There were many people reporting side effects such as bell's palsy, whole body convulsion. Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who died 15 minutes after receiving the vaccine. He said it's sad these were front line worker who were facing all these side effects. The outcome of the event was fatal.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021155151 same reporter, drug, event, different patient; Reported Cause(s) of Death: Two report of death related to the vaccine were reported in a young premature baby and 25-year-old young person who dies 15 minutes after receiving the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Depressed level of consciousness, Investigation, Pyrexia
Clinical narrative: almost comatose/couldn't get a response; really really hot/took her temperature it was 101.8/fever; This is a spontaneous report from a contactable consumer (patient's husband). This consumer reported for two patients. This is the first of two reports. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318 and expiration date 31May2021), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing Type 1 diabetic; Alzheimers from 2014 and ongoing, about 7 years ago; and covid-19 from Dec2020 to Dec2020. There were no concomitant medications. At 4 am yesterday morning (03Feb2021), she developed side effects. The patient's husband woke up at 4 am and touched the patient to make sure she was okay like he does every night. When he did, patient was really really hot. He took her temperature it was 101.8. She was almost comatose, and he couldn't get a response from her. He gave her fluid with a straw on her lips. At 7:30 am, 3.5 hours later, she was still hot. He was putting cold compresses on her. He called the hospice nurse, and she came and checked her vitals. She had a fever of 101.5 that time. He continued cold compresses. Her vitals were stable. Then about afternoon, her fever broke, and she became coherent. The rest of yesterday, and today she seems to be fine. She had a side effect that caused her to have a fever and be out of it. He couldn't get a response from her until noon yesterday. When the fever broke around noon, that is when she became more responsive and back to normal. Outcome of the events was recovered on 03Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156644 same reporter/drug, different patient/event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got diagnosed with Covid19 afterwards; got diagnosed with Covid19 afterwards; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, 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 immunisation. The patient's medical history and concomitant medications were not reported. The patient and had the first shot (unclear if Pfizer or Moderna) and got diagnosed with Covid-19 afterwards (dates unspecified). The outcome of the event diagnosed with Covid-19 was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.