chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Pancreatitis
Clinical narrative: pancreatitis; acute lower abdominal pain; This is a spontaneous report from a contactable pharmacist.  A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly on 18Dec2020 at 08:00 (as reported) at 46-years-old at a single dose for COVID-19 immunisation.  The patient medical history was not reported. The patient had no known drug allergy (NKDA). Concomitant medications included acetaminophen (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), sertraline hcl (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT); all taken for an unspecified indication from an unspecified date to an unspecified date (which were received within two weeks of vaccination).  On 18Dec2020 at 17:00, the patient experienced pancreatitis and acute lower abdominal pain; which required hospitalization and were assessed as medically significant. The patient was hospitalized for pancreatitis and acute lower abdominal pain for 3 days on unspecified dates.  The clinical course was reported as follows: The patient received the vaccine " at some point in the AM on 18Dec2020 (as reported)." That evening, the patient presented to the emergency department (ED) with acute lower abdominal pain. The patient was diagnosed with pancreatitis and was admitted overnight. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of pancreatitis and acute lower abdominal pain.  The clinical outcome of the events was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association , there is no evidence or argument to suggest a causal relationship between BNT162B2 and the events pancreatitis and acute lower abdominal pain. The events are likely due to an underlying medical condition. 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Extreme fatigue, muscle weakness
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anaphylactic reaction, Diarrhoea, Flushing, Haemorrhage
Clinical narrative: Developed vomiting, four to five times; Diarrhea; Abdominal pain; Slightly flushed face and minimum facial flowing; Numb ears/Numb body; Bleeding; Anaphylaxis; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis on 20Dec2020. Clinical course: the patient received the COVID vaccine on 19Dec2020, and since then she had developed onset of vomiting after 3 o' clock this morning on 20Dec2020, four to five times, numb ears, numb body. She also had diarrhea and bleeding. She had some abdominal pain and she also complained of having slightly flushed face and the minimum facial flowing. The outcome of events was unknown.  Information for Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event anaphylaxis was related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event bleeding with BNT162b2 can not 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vomiting
Clinical narrative: Developed vomiting, four to five times; Diarrhea; Abdominal pain; Slightly flushed face and minimum facial flowing; Numb ears/Numb body; Bleeding; Anaphylaxis; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2, via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis on 20Dec2020. Clinical course: the patient received the COVID vaccine on 19Dec2020, and since then she had developed onset of vomiting after 3 o' clock this morning on 20Dec2020, four to five times, numb ears, numb body. She also had diarrhea and bleeding. She had some abdominal pain and she also complained of having slightly flushed face and the minimum facial flowing. The outcome of events was unknown.  Information for Lot/Batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event anaphylaxis was related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the event bleeding with BNT162b2 can not 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram QT prolonged, Weight increased
Clinical narrative: She gained some weight and she thinks she was told she was 84 or 86 kg at the clinic. She weighs about 175 pounds; An EKG was done and she was told she had a prolonged qt interval; Her blood pressure went really high to 177/110; This is a spontaneous report from a contactable consumer. This consumer [patient] reported that the 48-year-old female patient received bnt162b2 (BNT162B2, Batch/lot number: EK5730), via intramuscular injection in left upper arm on 19Dec2020 07:30 am at single dose for covid-19 immunisation (Preventative). Medical history and concomitant medications were none. She got the Pfizer Biontech covid vaccine on the 19Dec. She was sent over to ER from the (clinic name) since her blood pressure went really high to 177/110 on 19Dec2020. Her blood pressure stayed around 170/100 and then she would rest for 10-15 minutes, the ER kept her there till her blood pressure went to about 144 or 150 and then she went home. She confirmed she was not admitted. She was told to go back to the ER if her blood pressure went up. An EKG was done and she was told she had a prolonged qt interval on 19Dec2020. She has not had an EKG since and was told to follow up with her doctor. Treatment: declines any, they just monitored her. When querying weight, states she knows she gained some weight and she thinks she was told she was 84 or 86 kg at the clinic. She weighs about 175 pounds. Reports she had some blood work done at the ER and it came back normal. She does not have any health conditions. She has an allergy to Cipro and fexofenadine. Vaccination Facility Type was Hospital. No Vaccine Administered at Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) required a visit to Emergency Room. No Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was None. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and mild itching at injection site.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Nausea
Clinical narrative: sudden rapid slightly irregular heartbeat; My pulse rate was in 148 and remained in the 140's/rapid heartbeat; associated nausea; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that the 45-year-old female patient received first dose of bnt162b2 (BNT162B2, Covid-19 Vaccine), on Arm left on 19Dec2020 09:30AM at single dose for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history was none. Known allergies was none. Allergies to medications, food, or other products was none. Concomitant medications were none. Facility type vaccine was other. No other vaccine in four weeks. Other medications in two weeks was none. The patient experienced "I had just received the vaccination was pulling into the area where you sit and wait in case you have an adverse reaction, was just looking at my phone and felt a sudden rapid slightly irregular heartbeat. Came on very suddenly with associated nausea I am a ER nurse with 22 years experience and so I began to take my pulse and record it with my phone, I wasn't sure if it was a reaction because I didn't fell like I " couldn't breathe" . Just a very rapid heartbeat. My pulse rate was in 148 and remained in the 140's. I beeped my horn on my car in case it was an adverse reaction. They placed a pulse ox on my finger and my heart rate then was 138 and O2 sats 98% . I sat for a bit and then it just went away. My heart rate was back down to the 70's." The events started from 19Dec2020 09:30 AM and outcome of the events was recoverd. No treatment was received. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Vaccine Facility information available. Location of injection information is available for all vaccines received on the same date.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events heart rate irregular, heart rate increased, and nausea cannot be excluded based on a compatible temporal relation. 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Periorbital swelling
Clinical narrative: left eye is getting puffy after receiving COVID-19 Vaccine today; left eye is getting itchy after receiving COVID-19 Vaccine today; This is a spontaneous report from a contactable healthcare professional (patient). A 62-year-old female patient received BNT162B2 (COVID-19 mRNA Vaccine BNT162B2), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included allergies to a lot of antibiotics. The patient's concomitant medication included Non-specified anti-inflammatory. The patient's left eye was getting puffy and left eye was getting itchy after receiving COVID-19 Vaccine on 21Dec2020. The events were reported as serious, medically significant. She said she is wondering if her left eye getting puffy and itchy is an allergic reaction and if she needs to seek treatment. Reported she did not have a prescription for the COVID-19 Vaccine. Reported her left eye being puffy and itchy has not gotten worse, but her left eye has not improved. Declined any treatment as she thought if she called Pfizer, Pfizer could tell her if she should get treatment. Reported she took an anti-inflammatory twice in the past 2 weeks, clarifying the last time she took the anti-inflammatory was over 4 days ago. The outcome of the events was not recovered.  Information on the Batch/Lot number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Impaired driving ability, Impaired work ability, Loss of consciousness
Clinical narrative: Blacked out; Vertigo; Diarrhea; Extreme Fatigue; sicker; This is a spontaneous report from a contactable nurse which is also the patient. A 48-year-old female patient received the first dose in the series of bnt162b2, lot number: EK5730, intramuscular in the left deltoid on 17Dec2020 at a single dose for COVID prevention. There were no medical history and concomitant medications. The patient received her COVID vaccine last Thursday evening, and she has been getting progressively sicker for the past couple of days on an unspecified date in Dec2020. On 20Dec2020, the patient experienced blacked out, vertigo, diarrhea, and extreme fatigue. The patient mentioned that she had extreme fatigue yesterday, with vertigo that started afternoon, and this morning her vertigo was so bad, that she blacked out in the shower, and the room is still spinning for her at this time. Outcome of the events blacked out and sicker was unknown, for the other events was not recovered. The seriousness of events blacked out, vertigo and diarrhea was reported as serious enough that she could not go to work, or get behind the wheel of a car so medically significant. Extreme fatigue was assessed as non-serious. The reported assessed the events extreme fatigue, vertigo, blacked out, and diarrhea as related to bnt162b2. The patient added that vertigo was worsened.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vertigo
Clinical narrative: Blacked out; Vertigo; Diarrhea; Extreme Fatigue; sicker; This is a spontaneous report from a contactable nurse which is also the patient. A 48-year-old female patient received the first dose in the series of bnt162b2, lot number: EK5730, intramuscular in the left deltoid on 17Dec2020 at a single dose for COVID prevention. There were no medical history and concomitant medications. The patient received her COVID vaccine last Thursday evening, and she has been getting progressively sicker for the past couple of days on an unspecified date in Dec2020. On 20Dec2020, the patient experienced blacked out, vertigo, diarrhea, and extreme fatigue. The patient mentioned that she had extreme fatigue yesterday, with vertigo that started afternoon, and this morning her vertigo was so bad, that she blacked out in the shower, and the room is still spinning for her at this time. Outcome of the events blacked out and sicker was unknown, for the other events was not recovered. The seriousness of events blacked out, vertigo and diarrhea was reported as serious enough that she could not go to work, or get behind the wheel of a car so medically significant. Extreme fatigue was assessed as non-serious. The reported assessed the events extreme fatigue, vertigo, blacked out, and diarrhea as related to bnt162b2. The patient added that vertigo was worsened.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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: Back pain, Pain
Clinical narrative: severe back pain/ back aches; body aches; inflammatory reaction; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable female nurse (patient) of unknown age reported that she received BNT162B2 (COVID VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got the Covid vaccine on Thursday (date not specified). She was taking ibuprofen (MOTRIN) (later clarified as ibuprofen) for anti-inflammatory. She went to a doctor visit yesterday (18Dec2020), and then her doctor told her that because ibuprofen was an anti-inflammatory, she shouldn't be taking it during, right after the vaccine because of inflammatory reaction and so patient stopped taking it and switched over to paracetamol (TYLENOL), now she was in severe back pain/ back aches and body aches, but anyways she was just going to end up taking it if this took much longer. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: From the information provided it is unclear which event is the intended subject of this spontaneous report and what is the reporter's perceived relationship to the vaccine. In addition, the lack of critical information (e.g. immunization date) makes a global medical assessment impossible. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: Patient experienced HA and dizziness approximately 40 minutes after vaccination. Patient was monitored to have diaphoresis with slightly elevated BP ranging from 138/72- 142/88 with HR98. Patient was monitored while standing and had no changes with dizziness but had an elevated HR of 114 with BP 131/84. After sitting again patient's BP 129/81 and HR went down to 88.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypertension
Clinical narrative: hypertension; tired; Headache; This is a spontaneous report from contactable nurse, the patient.  A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 19Dec2020 as a single dose for COVID-19 immunization.  Ongoing medical history included hypothyroidism. Other relevant medical history included anxiety and menopause.  Ongoing concomitant medications included estradiol (MANUFACTURER UNKNOWN) taken for menopause, progesterone (MANUFACTURER UNKNOWN) taken for menopause, and venlafaxine hydrochloride (EFFEXOR) taken for anxiety.  On 19Dec2020 at 18:00, the patient had a headache. On 20Dec2020, the patient experienced hypertension and was tired. The clinical course was as follows: the patient received her vaccine on 19Dec2020. At 18:00 on 19Dec2020, she started with a headache, and it was not a big deal. In the morning of 20Dec2020, her headache was bad, and then her blood pressure was 180/100. She had a headache and she was tired. She mentioned her baseline was 115/84. She had no coffee or anything, and as the day went by it was 140/90. She reported that the hypertension basically lasted for one day and in the morning of 21Dec2020 it was 120/88. As of 21Dec2020, she did not have a headache. The clinical outcomes of the hypertension and headache were recovered on unknown dates in Dec2020; while that of the tiredness was unknown. The patient assessed the hypertension and headache as serious for being medically significant and related to the vaccine; however, the seriousness and causality assessment were not provided for the tiredness.; Sender's Comments: A causal association between BNT162B2 and the events hypertension and headache cannot be excluded based on a compatible temporal relation. 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.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Palpitations, Pruritus, Tremor
Clinical narrative: The patient felt very hot around 15 min post vaccine, felt anxious. Felt her HR was racing, Watch said it was 103. Let the RN know and HR was then measured at 125 bpm. BP was 140 which is high for the patient (baseline around 100 systolic). She felt shaky. The RN said she saw a few hives on her chest and it was a bit itchy. They gave her some water and juice. She felt better and the hives resolved on their own.  She then was given Zyrtec.  Her HR is 85 when I spoke to her, 30 min post vaccine, and BP is 130 systolic. No wheezing, no SOB, O2 sat was normal the entire time.  She still felt shaky and anxious.  Called 2 hours after vaccine administration and she felt normal.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Tryptase, Urticaria
Clinical narrative: The patient felt very hot around 15 min post vaccine, felt anxious. Felt her HR was racing, Watch said it was 103. Let the RN know and HR was then measured at 125 bpm. BP was 140 which is high for the patient (baseline around 100 systolic). She felt shaky. The RN said she saw a few hives on her chest and it was a bit itchy. They gave her some water and juice. She felt better and the hives resolved on their own.  She then was given Zyrtec.  Her HR is 85 when I spoke to her, 30 min post vaccine, and BP is 130 systolic. No wheezing, no SOB, O2 sat was normal the entire time.  She still felt shaky and anxious.  Called 2 hours after vaccine administration and she felt normal.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching really bad; This is a spontaneous report from a contactable pharmacist.  A 43-year-old female patient received the first dose of the bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899 and Expiration Date: Mar2021), intramuscularly on 17Dec2020 at 43-years-old at 0.3 mL, single for COVID-19 immunization. The vaccination was administered in a hospital. There was no history of previous immunizations with a Pfizer vaccine considered as suspect; and there were no additional vaccines administered on the same date of the Pfizer suspect; and there were no prior vaccinations (within 4 weeks). It was unknown if the patient had adverse events (AEs) following prior vaccinations. Medical history included obesity from an unknown date and unknown if ongoing, hay fever from an unknown date and unknown if ongoing. There was no family medical history relevant to the AEs. Concomitant medications included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication from an unspecified date to ongoing, metoprolol (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to ongoing, montelukast sodium (SINGULAIR) taken for hay fever from an unspecified date to an unspecified date, omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication from an unspecified date to ongoing. On 17Dec2020, the patient experienced: itching really bad; which was assessed as medically significant. There were no visits to an emergency room or a physician office as a result of the events.   The clinical course was reported as follows: The patient started itching really bad within five minutes of receiving the vaccine. The patient was given a shot of diphenhydramine hydrochloride (BENADRYL) and the itching stopped. This was the patient's first dose of COVID vaccine.  It was unknown to the reporter if the patient would continue the vaccine series. Therapeutic measures were taken as a result of itching really bad (pruritus). The clinical outcome of the event, itching really bad, was recovered on 17Dec2020. The causality assessment from the Primary Source Reporter was reported as related; via the Method of assessment.; Sender's Comments: A causal association between BNT162B2 and the event pruritus cannot be excluded based on a compatible temporal relation. 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Headache, Peripheral coldness, Peripheral swelling, Pruritus
Clinical narrative: Approximately 4 hours after vaccine, noted hives/welts on arms, took cetirizine. Went to bed. ~8pm (4 hours later) was very itchy, swollen, discolored face, face felt cold/body hot. No difficulty breathing.  Lips purplish, arms swollen.  Went to ED.  Given benadryl, 2 other pills, watched for 30 minutes.   No epinephrine.  Hives improved, released,  had headache.  Next day improved, but still mild headache and groggy.  Hives gone completely 48 hours. Mild headache persists.  No prior experience like this.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin warm, Somnolence, Swelling face, Urticaria
Clinical narrative: Approximately 4 hours after vaccine, noted hives/welts on arms, took cetirizine. Went to bed. ~8pm (4 hours later) was very itchy, swollen, discolored face, face felt cold/body hot. No difficulty breathing.  Lips purplish, arms swollen.  Went to ED.  Given benadryl, 2 other pills, watched for 30 minutes.   No epinephrine.  Hives improved, released,  had headache.  Next day improved, but still mild headache and groggy.  Hives gone completely 48 hours. Mild headache persists.  No prior experience like this.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: profound dizziness; This is a spontaneous report from a contactable nurse.  A 54-year-old female patient received BNT162B2 (lot number: EK5730), intramuscular at the right arm  on 17Dec2020 18:00 at 0.3 mL for COVID-19 immunization at a hospital. There were no medical history and concomitant medications. The patient experienced which she described as bizarre side effect  of profound dizziness, almost like vertigo, states she was having to hold onto a wall, considered medically significant by the reporter on 20Dec2020 12:00. The patient recovered from the event on 21Dec2020, 10:00.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event dizziness cannot be excluded. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia, Mucous stools
Clinical narrative: Experiencing some stool that had a little bit of blood and kind of mucus; Experiencing some stool that had a little bit of blood and kind of mucus; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. This past Friday, so on the 18Dec2020 got the first shot of the COVID 19 Vaccine and starting yesterday (19Dec2020), the patient started experiencing some stool that had a little bit of blood and kind of mucus. So, patient just wanted to know if that is a side effect of the vaccine that could happen or if anyone else have also reported symptoms like that. Events outcome was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Flushing, Paraesthesia, Pruritus
Clinical narrative: itching; tingly feeling; face appeared more flushed; slight shortness of breath; This is a spontaneous report from a contactable pharmacist. A 63-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscularly in right arm on 18Dec2020 14:30 at single dose for Covid-19 immunisation. Medical history included allergic reactions (allergies to medications, food, or other products: Yes, numerous). No other vaccines administered in four weeks. Other medications in two weeks was numerous. Approximately 10-15 minutes after receiving COVID-19 vaccine (18Dec2020 14:45), patient reported itching, tingly feeling, face appeared more flushed. Seemed anxious due to history of allergic reactions and reported slight shortness of breath. Treated with diphenhydramine 50 mg PO and epinephrine 0.5 mg IM and transported to Emergency Department. Observed in that area and released a few hours later as symptoms resolved. The outcome of events was recovered on 18Dec2020.; Sender's Comments: A causal association between BNT162B2 and the events pruritus, paraesthesia, flushing, and dyspnea cannot be excluded based on a compatible temporal relation. 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Nausea and lightheadedness began about 20 minutes after administration. Lightheadedness abated after about 1 hour, nausea intensified and persisted, abated after about 26 hours. Fatigue  began about 2 hours after administration. Fatigue abated after 24 hours. Severe headache (migraine) began about 2 hours after administration, still persists at 28 hours mark. Injection site tenderness, swelling and redness (2-inch diameter, bright red)  noted about 8 hours after administration,  tenderness persists, redness beginning to abate  at 28 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea
Clinical narrative: Nausea and lightheadedness began about 20 minutes after administration. Lightheadedness abated after about 1 hour, nausea intensified and persisted, abated after about 26 hours. Fatigue  began about 2 hours after administration. Fatigue abated after 24 hours. Severe headache (migraine) began about 2 hours after administration, still persists at 28 hours mark. Injection site tenderness, swelling and redness (2-inch diameter, bright red)  noted about 8 hours after administration,  tenderness persists, redness beginning to abate  at 28 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Swelling face
Clinical narrative: Face swell, Heart rate 108, Blood pressure 133/87, pregnant 35 weeks
Sex: M
Vaccine: COVID19
Symptoms: Basal ganglia haemorrhage, Condition aggravated, Hypertension
Clinical narrative: Admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2020 at single dose for COVID-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. After vaccination, the patient was admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed in 2020. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Injection site erythema, Injection site induration
Clinical narrative: Redness around injection site, swollen, hardness at site, fatigue, hot/cold spells, chills.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Redness around injection site, swollen, hardness at site, fatigue, hot/cold spells, chills.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory distress, SARS-CoV-2 test negative
Clinical narrative: resp distress; This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 16Dec2020 12:00 pm at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced respiratory distress on 19Dec2020, he was hospitalized for three days. Patient received treatment for the adverse event. Since the vaccination, the patient has been tested for COVID-19 with nasal swab on 19Dec2020, it was negative. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown. The event was serious, the seriousness criteria was Caused/prolonged hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Sneezing, Throat irritation
Clinical narrative: late Friday had sneezing, mild coughing, scratching throat, mild body ache, headache. Still have same symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Feeling hot, Headache, Hypoacusis, Rash erythematous
Clinical narrative: blood pressure shot up to 205/112/blood pressure went down to 136/75; head hurt; couldn't hear that well; pulse 137; a heat wave go through her body up to her head; red rash and hives; red rash and hives; This is a spontaneous report from a contactable other healthcare professional (Patient). A 62-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 21Dec2020 16:00 at single dose for COVID-19 immunization, vaccine location provided as Left arm.  Medical history included Penicillin allergy. The patient's concomitant medications were not reported. After about 10 minutes receiving the vaccine on 21Dec2020 16:15, the patient felt a heat wave go through her body up to her head, couldn't hear that well and head hurt. Her blood pressure shot up to 205/112, pulse 137, red rash and hives. The patient was transported via parametics to the Emergency Room for observation. Her blood pressure went down to 136/75. No treatment was received for all the event. The outcome of the events was recovered on 21Dec2020.  Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event blood pressure increased cannot be excluded based on a compatible temporal relation. 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: blood pressure shot up to 205/112/blood pressure went down to 136/75; head hurt; couldn't hear that well; pulse 137; a heat wave go through her body up to her head; red rash and hives; red rash and hives; This is a spontaneous report from a contactable other healthcare professional (Patient). A 62-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 21Dec2020 16:00 at single dose for COVID-19 immunization, vaccine location provided as Left arm.  Medical history included Penicillin allergy. The patient's concomitant medications were not reported. After about 10 minutes receiving the vaccine on 21Dec2020 16:15, the patient felt a heat wave go through her body up to her head, couldn't hear that well and head hurt. Her blood pressure shot up to 205/112, pulse 137, red rash and hives. The patient was transported via parametics to the Emergency Room for observation. Her blood pressure went down to 136/75. No treatment was received for all the event. The outcome of the events was recovered on 21Dec2020.  Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event blood pressure increased cannot be excluded based on a compatible temporal relation. 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient evaluated and monitored following vaccine. Developed nausea and lightheadedness approximately 20 minutes after dose given. Patient reports that she hadn't had anything to eat or much to drink in the hours leading up to vaccine as she and her husband were going to get lunch after the vaccination appointment. Patient has a history of syncope/presyncope after a blood draw in the past.  Patient had no other stx other than very transient nausea and lightheadedness, which improved significantly in the hour that she was monitored.   BP at time of discharge from clinic was 105/73; pulse 67
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Pfizer.  Only upper lip swelled slightly (noted by coworkers as well) for about 24 hours.  Of note, I had Juvaderm filler to the upper lip only late January 2020.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Tremor
Clinical narrative: About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; About 7 minutes into my observation period my heart rate rose to 170 bpm and I felt warm and shaky. It took around 15 minutes to return to 70-80; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at first dose right arm on 21Dec2020 11:45 am at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Zithromax and morphine both cause nausea and vomiting. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. About 7 minutes into patient's observation period, at 21Dec2020 11:45 am, her heart rate rose to 170 bpm and she felt warm and shaky. It took around 15 minutes to return to 70-80. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered. The events were non-serious.; Sender's Comments: A causal association between BNT162B2 and the event heart rate increased cannot be excluded based on a compatible temporal relation. 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Iridocyclitis, Lacrimation increased, Ocular hyperaemia, Vision blurred
Clinical narrative: A day after having the vaccine, I experienced eye soreness in my right eye. The next morning both my eyes were blood shot. I administered eye drops and went on about my day. Late that evening they were really red and watery and my vision was blurred. I went to the optometrist on Monday morning and was diagnosed with Primary iridocyclitis, bilateral. My iris had been attached to my lens from the inflammation, but had detached it self. I was put on steroid drops and made to keep my eyes dilated until my follow up appointment. Went to my follow up appointment today December 28, 2020. My eyes are looking better, but not back to normal yet. Advised to keep administering my steroids drops and only use the dilation drops every other day. I will follow up on Thursday.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diabetes mellitus, Laboratory test
Clinical narrative: New diagnosis of diabetes 5 days after receiving vaccine with no past medical of DM and no family history.; This is a spontaneous report from a contactable Nurse (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EJ1685), via an unspecified route of administration on 18Dec2020 14:00 at arm left at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included asthma and hypertension. The patient had no known drug allergies. Concomitant medication included cetirizine, budesonide, formoterol fumarate (SYMBICORT), escitalopram oxalate (LEXAPRO), montelukast and omalizumab (XOLAIR). No other vaccine in four weeks prior to the COVID vaccine. The patient experienced new diagnosis of diabetes 5 days after receiving vaccine with no past medical of diabetes mellitus and no family history. The event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Adverse event start date was 19Dec2020 06:00 AM. Treatment received included fluid bolus, computerized tomogram (CT) scan and labs. The patient underwent lab tests and procedures which included computerized tomogram and laboratory test with unknown results on Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was recovered with lasting effects.; Sender's Comments: The reported diabetes was unlikely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), considering the latency of the onset of the event.  A possibility that the vaccination unmarked subject's diabetes cannot be completely excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Nurse that fainted after the vaccine; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer.  A patient of unspecified age and gender 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's medical history and concomitant medications were not reported. It was reported that the patient was a nurse who received the vaccine and did a live press conference on TV 15 minutes later and, as a result, she fainted. The event outcome was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.