chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient got Covid after the first dose of the vaccine; patient got Covid after the first dose of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable Nurse reporting for a patient. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On an unknown date the patient got Covid after the first dose of the vaccine. The reporter was inquiring how long the patient should wait before getting a second dose. The clinical outcome of the patient got Covid after the first dose of the vaccine was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; 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 COVID-19 and suspected LOE.  There is limited information provided in this report.  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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased
Clinical narrative: BP 225/109; heart rate 52; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date: Not available/provided by the reporter at the time of report) via an unspecified route of administration on 10Feb2021 (Wednesday) at single dose for Covid-19 immunization. The patient is vaccinated in a hospital. Medical history included that the patient does have a history of high blood pressure and takes clonidine twice a day. The patient previously took first dose of bnt162b2 on unspecified date at the hospital for covid-19 immunization; and previously took clonidine on unspecified date for high blood pressure. It was reported that late on 11Feb2021 she texted her symptoms, BP 225/109, heart rate 52 and temp. 99.1. She had notified her doctor who gave her instructions to help her BP. The events took place after use of product. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  This male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that received first dose of the covid-19 vaccine on 27Jan2021, he tested positive for covid-19 on 05Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Feb2021, sars-cov-2 test: positive on 11Feb2021 (He went again yesterday to be tested and tested  positive).  He asked if he should receive the second dose of the vaccine next Wednesday.  Information on the Batch/Lot number has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Facial paralysis, Ocular discomfort, Speech disorder
Clinical narrative: Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, "I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else." Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 "two weeks ago" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: cognitive issue (dementia); This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 05Feb2021, at a single dose, for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced cognitive issue (dementia). The patient wanted to know about her second dose schedule. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: was admitted in the hospital last Friday morning for Pneumonia; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable consumer. This female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history includes unspecified underlying conditions. The patient was on unspecified concomitant medications. On an unknown date, the patient had pneumonia and was admitted to the hospital on 05Feb2021. The patient is on oxygen at night while asleep. The clinical outcome of pneumonia was unknown. The reporter doubts if it is related to the Pfizer vaccine  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The event pneumonia more likely represent an intercurrent medical condition which was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a Pfizer-sponsored program Covax US Support, received from a contactable consumer (patient's daughter). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Feb2021 as a SINGLE DOSE for COVID-19 vaccination.  The patient's medical history and concomitant medications were not reported. The patient experienced horrible dizziness on 08Feb2021 that resulted in being hospitalized on unknown date. Outcome of the event was unknown.  Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program.  A male patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient medical history was not reported. Concomitant medications were not reported. On an unspecified date, the patient experienced: passed out (hospitalization, medically significant). The patient's mother called-in on-behalf of her son who passed out in a restaurant and was taken into the hospital due to this emergency. The patient's mother was worried saying that her son was due for the second dose of the COVID-19 vaccine. The patient's mother was unable to identify when her son received the first shot of the vaccine. The patient's mother was also unable to identify why her son passed out. The mother's concern was that her son already missed the second dose. The clinical outcome of the event, passed out, was unknown.   The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Diagnosed with cellulitis; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient was diagnosed with cellulitis on an unspecified date. Therapeutic measures were taken as a result of the event and included treatment with KEFLEX for 10 days. The patient outcome of the event was unknown.  The information on the batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful case assessment. Based solely on an implied temporal association causality between event cellulitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mental impairment, SARS-CoV-2 test
Clinical narrative: Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a contactable other hcp.   A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration arm right single dose on 05Feb2021 for COVID-19 immunisation. First dose lot#EL8982, arm right (IM) was received on 15Jan2021, 10:00. Medical history included drug hypersensitivity (to sulfa drugs) from an unknown date. The patient's concomitant medications were not reported. The patient experienced mental fog on 05Feb2021 15:00, massive head consuming headache on 05Feb2021 15:00, extreme fatigue on 05Feb2021 15:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. The events outcome was recovered in Feb2021  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a causal relationship between event "mental fog" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable non-healthcare professional reporting for a patient. A 72-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 post vaccination by nasal swab on 09Feb2021 which had negative results. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 10Feb2021, the patient experienced shingles. The patient was hospitalized for the event on an unknown date for 2 days. It was unknown if the patient received treatment.  The clinical outcome of the event shingles was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Lymphoma, Neck pain, Pain
Clinical narrative: pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Pyrexia
Clinical narrative: 1.  Woke up following morning , I had difficulty urinating. 2.  99.3 fever the following day around 4 pm.  Took 2 tablets of tylenol. 3.  Fever gone after a few hours. 4.   Still had difficulty urinating whole day up to evening of the 2nd day.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Chills, Dizziness
Clinical narrative: Within 5 minutes I Became extremely hot.  It started from feet up to face, heart palpitations.  I could feel my heart beating in my chest.  Uneasy feeling, something was wrong.  Dizzy,  remained with ice pack and wet towel for 20 minutes.  After I left I felt off and dizzy.  I had a difficult time driving .     That evening I had soreness at injection site for 3 days.  Headache and dizziness for 3 days.  Chills for 1 day.  Back pain  and hip pain still to this day.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Impaired driving ability, Injection site pain, Palpitations
Clinical narrative: Within 5 minutes I Became extremely hot.  It started from feet up to face, heart palpitations.  I could feel my heart beating in my chest.  Uneasy feeling, something was wrong.  Dizzy,  remained with ice pack and wet towel for 20 minutes.  After I left I felt off and dizzy.  I had a difficult time driving .     That evening I had soreness at injection site for 3 days.  Headache and dizziness for 3 days.  Chills for 1 day.  Back pain  and hip pain still to this day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Faeces soft, Feeling abnormal, Headache
Clinical narrative: Woke up twice not really feeling right.  Restless sleep and woke up the second time with stomach upset as if going to have diarrhea.  minor lower stomach cramping.   Did have a bowel movement within 2 hours that was soft with lower abdominal discomfort but wasn't diarhhea.  Felt as if a headache was starting
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Sleep disorder
Clinical narrative: Woke up twice not really feeling right.  Restless sleep and woke up the second time with stomach upset as if going to have diarrhea.  minor lower stomach cramping.   Did have a bowel movement within 2 hours that was soft with lower abdominal discomfort but wasn't diarhhea.  Felt as if a headache was starting
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Hypoaesthesia, Swelling, Swelling face
Clinical narrative: Lost 100% of vision in left eye and 50% of vision in right eye; Numbness of face and neck; Numbness of face and neck; Swelling of face and neck; Swelling of face and neck; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot number EN6201), via an unspecified route of administration in right arm, on 10Feb2021 at 15:45, at single dose, for COVID-19 immunisation. Medical history included blood cholesterol increased. Patient did not have known allergies, did not have COVID-19 prior to vaccination and was not pregnant at time of events or vaccination. There were no concomitant medications. Patient did not receive other different vaccines in four weeks. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, lot# EL3244), in arm left, on 20Jan2021 at 15:45, for COVID-19 immunisation. The patient experienced lost 100% of vision in left eye and 50% of vision in right eye on 10Feb2021 at 17:30 with outcome of recovered on 11Feb2021 at 07:30 (after 14 hours), numbness of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours), swelling of face and neck on 10Feb2021 at 17:30 with outcome of recovered on 12Feb2021 at 09:30 (after 40 hours). Patient did not tested positive for COVID-19 after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ?Pfizer-BioNTech COVID-19 Vaccine EUA?
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Dysarthria, Facial paralysis, Unresponsive to stimuli
Clinical narrative: Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Electrocardiogram, Full blood count, Headache, Hypoaesthesia
Clinical narrative: Patient was brought to clinic by ambulance for an unwitnessed syncopal event with LOC for unknown period of time. He reported no memory of event. No post-ictal confusion when found. Upon arrival in clinic, patient reported headache, mild confusion, bilateral facial numbness across cheeks and forehead, pressure behind eyes, light sensitivity, and nausea with eye movement. Time between receiving vaccine and event possibly 2 hours.  Following assessment in clinic, patient was referred to emergency department for further evaluation.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Ocular discomfort, Photophobia, Sinus bradycardia
Clinical narrative: Patient was brought to clinic by ambulance for an unwitnessed syncopal event with LOC for unknown period of time. He reported no memory of event. No post-ictal confusion when found. Upon arrival in clinic, patient reported headache, mild confusion, bilateral facial numbness across cheeks and forehead, pressure behind eyes, light sensitivity, and nausea with eye movement. Time between receiving vaccine and event possibly 2 hours.  Following assessment in clinic, patient was referred to emergency department for further evaluation.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Troponin, Urine analysis
Clinical narrative: Patient was brought to clinic by ambulance for an unwitnessed syncopal event with LOC for unknown period of time. He reported no memory of event. No post-ictal confusion when found. Upon arrival in clinic, patient reported headache, mild confusion, bilateral facial numbness across cheeks and forehead, pressure behind eyes, light sensitivity, and nausea with eye movement. Time between receiving vaccine and event possibly 2 hours.  Following assessment in clinic, patient was referred to emergency department for further evaluation.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Experiencing extreme itching on site of vaccine.; This is a spontaneous report from a contactable consumer reported for himself.  A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot # EN6201, via unknown route at left arm on 18Feb2021 at 12:15 (at the age of 78-year-old) at single dose for covid-19 immunization. The patient received the first dose of the same vaccine on 28Jan2021 at 12:15 AM at the left arm from lot # EL3248. The patient experienced extreme itching on site of vaccine. The outcome of the event was not recovered. No COVID prior vaccination. Patient has not been tested for COVID-19. Adverse event result in hospitalization, Life threatening illness, Disability or permanent damage, Congenital anomaly.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia; This is a spontaneous report from a non-contactable consumer.   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced thrombocytopenia. Hospitalization required. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hyporesponsive to stimuli, Syncope
Clinical narrative: Patient fainted and hyporesponsive.; Patient fainted and hyporesponsive.; This is a spontaneous report from a non-contactable other healthcare professional.  A 21-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: En9265, intramuscular on 13Feb2021 at 14:00 (at the age of 21 years old) as a single dose in the right arm for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient fainted and was hyporesponsive on 13Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovered in Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events fainted and was hyporesponsive and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), cannot be excluded. 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm painful; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9265), via an unspecified route of administration in the left arm, on 03Feb2021 at 12:05 (at the age of 86-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no family history related to the adverse events. The patient had no prior adverse events to vaccinations nor any prior vaccinations within four weeks of vaccination. There were no additional vaccines administered on the same day. The patient experienced left arm painful on 06Feb2021, which was reported with disability. The clinical course was reported as follows: The first 3-4 days (as reported), there were no side effects; however, her arm was painful for days 5- 7, and on day 9, it was still a little sore but better. Therapeutic measures were taken as a result of the event, which included a visit to the chiropractor. The clinical outcome of left arm painful was recovering. The primary reporter (patient) assessed the causality between the event and the suspect product as related.; Sender's Comments: Based on the information available, a causal relationship between event "left arm painful" and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Back pain, Periorbital cellulitis
Clinical narrative: preseptal cellulitis eyelid; hurt her back, aggravating the back pain; hurt her back, aggravating the back pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm on 20Jan2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included breast cancer from 2015, back pain (which predated vaccination with BNT162B2), cholesterol, diabetes, blood pressure, kidney stones, vitamin D low, allergy, depression, lichen sclerosus and hair loss. Ongoing concomitant medications included simvastatin for cholesterol, empagliflozin (JARDIANCE) for diabetes, metformin for diabetes from 20Dec2020, linagliptin (TRADJENTA) for diabetes, hydrochlorothiazide/valsartan for blood pressure, potassium citrate (UROCIT-K) for kidney stones, vitamin D for vitamin D low, fexofenadine hydrochloride (ALLEGRA) for allergy, anastrozole (ARIMIDEX) for depression, clobetasol propionate for lichen sclerosus, lidocaine hydrochloride (ASPERCREME WITH LIDOCAINE) for back pain, minoxidil for hair loss. There were no additional vaccines administered on the same date as BNT162B2, and no vaccinations within 4 weeks prior of BNT162B2. On 06Feb2021, the patient hurt her back, aggravating the back pain. On 06Feb2021, the patient experienced preseptal cellulitis of the eye lid. The events required a visit to the emergency room and physician office but did not require admission to the hospital. The patient went to the doctor on 06Feb2021 for preseptal cellulitis of the eyelid and was  treated with cephalexin 250 mg orally four times a day from 06Feb2021 to 11Feb2021, and dexamethasone/neomycin/ polymyxin b (NEOPOLYDEX) from 06Feb2021 and ongoing three times per day. On 08Feb2021, the patient took paracetamol (TYLENOL) 500 mg for the back pain. The patient went to the doctor for the back pain on 11Feb2021 and was prescribed meloxicam 15 mg once daily and cyclobenzaprine 10 mg, (take one half by mouth as needed). Reportedly, the cyclobenzaprine did absolutely nothing. The patient also took paracetamol (TYLENOL ARTHRITIS) 650 mg per her doctor's recommendation. The clinical outcome of preseptal cellulitis eyelid was resolving, and of "hurt her back, aggravating the back pain" was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Helicobacter infection, Insomnia
Clinical narrative: H.pylori infection; had a really bad headache; sore left arm / hurt and ached all the way down and when trying to open it hurt / could only lay on her back and not her side because it hurt; Chills; she hardly slept all night; She can hardly raise her left arm; has a big bump to left arm; quarter size red area and redness all around the area to left arm; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at 15:00, for COVID-19 immunization. The first BNT162B2 vaccine dose was given on an unknown date. Medical history included ongoing hypertension; she was taking two unspecified medications already. The day following vaccination, the patient experienced a really bad headache, arm sore and chills. She left work, went home and felt like she started to feel better. She hardly slept all night and her left arm hurt and ached all the way down and when trying to open it hurt. She can hardly raise her left arm, it hurt so bad. On left arm she had a big bump and quarter size red area and redness all around the area. She was having headache again. She could only lay on her back and not her side because it hurt. At 3:30 she took paracetamol (TYLENOL) and that took the edge off. On an unspecified date in Feb2021 she was diagnosed with H. pylori infection and had been on an antibiotic. She took ibuprofen (ADVIL) at about 8:30 and put heating pad on her arm. She was regretting the vaccine because she did not know that it would be this bad. Events outcome was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Skin disorder
Clinical narrative: H.pylori infection; had a really bad headache; sore left arm / hurt and ached all the way down and when trying to open it hurt / could only lay on her back and not her side because it hurt; Chills; she hardly slept all night; She can hardly raise her left arm; has a big bump to left arm; quarter size red area and redness all around the area to left arm; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at 15:00, for COVID-19 immunization. The first BNT162B2 vaccine dose was given on an unknown date. Medical history included ongoing hypertension; she was taking two unspecified medications already. The day following vaccination, the patient experienced a really bad headache, arm sore and chills. She left work, went home and felt like she started to feel better. She hardly slept all night and her left arm hurt and ached all the way down and when trying to open it hurt. She can hardly raise her left arm, it hurt so bad. On left arm she had a big bump and quarter size red area and redness all around the area. She was having headache again. She could only lay on her back and not her side because it hurt. At 3:30 she took paracetamol (TYLENOL) and that took the edge off. On an unspecified date in Feb2021 she was diagnosed with H. pylori infection and had been on an antibiotic. She took ibuprofen (ADVIL) at about 8:30 and put heating pad on her arm. She was regretting the vaccine because she did not know that it would be this bad. Events outcome was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; nausea; vomiting; GI Upset; This is a spontaneous report from a contactable physician and consumer. A 69-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration 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. The patient experienced diarrhea, nausea, vomiting, GI upset on 30Dec2016. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Sinusitis
Clinical narrative: when patient got the flu shot had at least 5 sinus infections a year; Initial information was received on 11-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown age and gender) who experienced sinus infections (at least 5) a year (sinusitis), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number; dosing details and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious sinus infections (at least 5) a year (sinusitis) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that patient had not had that poison for three years then and had not been sick once before that.   It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: Not provided   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  Result of assessment was not reported.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Condition aggravated
Clinical narrative: patient get more sick; Initial information received on 16-Feb-2021 regarding an unsolicited valid non-serious case from non-healthcare professional.  This case involves patient (unknown demographics) who get more sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient get more sick (illness) (non-serious) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome is unknown for illness.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic to them; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves adult patient (gender not specified) who was allergic to them (Allergy to vaccine), while patient received INFLUENZA VACCINE.    It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergic to them (allergy to vaccine) unknown latency following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  The reporter assessed the causal relationship with suspect vaccine as related.    There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Administered 2 vaccines (Adacel and Flublok) to a pregnant patient, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Medical Information (Reference number- 00479733) and transmitted to Sanofi on 17-Feb-2021.  This case involves a 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of administered two vaccines (adacel and flublok) to a pregnant patient (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  The date of last menstrual period was not reported.  The estimated due date is 05-Apr-2021.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK).  On an unknown date, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot U6846AA and expiry date: 16-Oct-2022] via an intramuscular route in right arm for prophylactic vaccination.  It was reported that, vaccine presentation for specific vaccine if baby was delivered: delivery date and if baby experienced an adverse event- not delivered. Inform that they would be receiving a follow up questionnaire and it was done. All pregnancy cases were added to the registry, it was an FDA requirement.  Product used: Used.  Still using product: No.  It was the case of vaccine exposure during pregnancy [Latency on the same day].   Pregnancy outcome was unknown at the time of report.  Details of laboratory data not reported.  There will be no information available on the batch number for this case.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Metabolic function test, Swelling of eyelid, Throat tightness, Urticaria
Clinical narrative: URTICARIA, THROAT TIGHTNESS, EYELID SWELLING
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, vomitting, diarhea, dizziness
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Within 10 minutes:  anxiety, dizziness   Within 1 hour: diarrhea, anxiety, mild trouble breathing   2 days later: trouble breathing, mild fever
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: 103 fever from 10:30 pm-7 am. Low grade fever 100 from 7am-3pm. Headache(24 hrs), nausea(during high fever period), chills(during high fever period), fatigue (34 hours)
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: Hives 3.5 days after 2nd vaccination was administered, along with transient lower lip swelling. Eye swelling appeared 5 days after vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, legs, back, stomach, chest  & back. treated with Benedryl Cream and Aveeno Bath Power.  Starting to go away on 1 Mar 21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymph node palpable, Lymphadenopathy, Oedema peripheral
Clinical narrative: 24 hrs post first dose 1 lymph node last side of neck swollen, hard, immobile, and painful.  48 hrs post first dose lymph nodes through left armpit and left proximal upper arm swollen, hard, immobile, and painful.  60 hrs post first dose lymph nodes throughout  left arm swollen, hard, immobile, and painful.  Arm generalized +1 edema. Pain 3 on scale of 1-10. Currently 13 days post dose.  Arm remains unchanged.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Covid arm. Swelling, pain, big rash, itchy, firmness under skin (knots)
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Severe joint pain in left arm - specifically elbow, hand
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Dizziness, Fatigue, Feeling hot
Clinical narrative: Dizzness Upset stomach Blurry eyes Hot in face Anxiousness Fatigue
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Dizzness Upset stomach Blurry eyes Hot in face Anxiousness Fatigue
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, then mild fever, muscle aches, head ache
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: Muscle pain, fatigue, chills, headache
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Headache  nausea  chills weakness  severe arm pain right arm .    Recovered in 10 hours followed by slight headache for several days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Sleep disorder
Clinical narrative: Rash all over body for three weeks now; started on torso and slowly spread. Itchiness prevents sleeping through the night.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: pain in arm, slight redness and swelling at the injection site
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Chills, dizziness, nausea, vomiting, diarrhea, fatigue
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills, dizziness, nausea, vomiting, diarrhea, fatigue
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: I have a large red square on my arm just below the injection site...........it is about 2x3 inches and itches
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Decreased appetite, Fatigue, Gait disturbance, Headache
Clinical narrative: 35 minutes after vaccine: Slight headache & slight nausea 6 hours after vaccine: Left upper arm extremely stiff & tender. Tired/sleepy feeling. 8 hours after vaccine: EXTREME exhaustion, legs, arms stiff [unable to turn over in bed] (Water/Coffee/Tea intake). 1 day after vaccine: VERY EXTREME exhaustion, difficulty walking, moving. No appetite. No bowel movements(Water/Coffee/Tea intake-very high-very little urination)-slept 10 hours. Vaccination site extraordinarily sore & stiff. Still difficult to turn over in bed. 2 day after vaccine: EXTREME exhaustion occurs in waves.  Sleeping over 12 hours-cannot stay awake. Stiffness subsiding.  Vaccination site no longer sore, stiffness subsiding.   3 day after vaccine.  Still exhausted.  stiffness very light.  Still require 10 plus hours of sleep.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Nausea, Somnolence, Tenderness
Clinical narrative: 35 minutes after vaccine: Slight headache & slight nausea 6 hours after vaccine: Left upper arm extremely stiff & tender. Tired/sleepy feeling. 8 hours after vaccine: EXTREME exhaustion, legs, arms stiff [unable to turn over in bed] (Water/Coffee/Tea intake). 1 day after vaccine: VERY EXTREME exhaustion, difficulty walking, moving. No appetite. No bowel movements(Water/Coffee/Tea intake-very high-very little urination)-slept 10 hours. Vaccination site extraordinarily sore & stiff. Still difficult to turn over in bed. 2 day after vaccine: EXTREME exhaustion occurs in waves.  Sleeping over 12 hours-cannot stay awake. Stiffness subsiding.  Vaccination site no longer sore, stiffness subsiding.   3 day after vaccine.  Still exhausted.  stiffness very light.  Still require 10 plus hours of sleep.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 35 minutes after vaccine: Slight headache & slight nausea 6 hours after vaccine: Left upper arm extremely stiff & tender. Tired/sleepy feeling. 8 hours after vaccine: EXTREME exhaustion, legs, arms stiff [unable to turn over in bed] (Water/Coffee/Tea intake). 1 day after vaccine: VERY EXTREME exhaustion, difficulty walking, moving. No appetite. No bowel movements(Water/Coffee/Tea intake-very high-very little urination)-slept 10 hours. Vaccination site extraordinarily sore & stiff. Still difficult to turn over in bed. 2 day after vaccine: EXTREME exhaustion occurs in waves.  Sleeping over 12 hours-cannot stay awake. Stiffness subsiding.  Vaccination site no longer sore, stiffness subsiding.   3 day after vaccine.  Still exhausted.  stiffness very light.  Still require 10 plus hours of sleep.