chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Heart rate irregular
Clinical narrative: blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation.  Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination.  Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT).  The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully 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: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Got the first Pfizer COVID Vaccine and today I tested positive for COVID; Got the first Pfizer COVID Vaccine and today I tested positive for COVID; Congestion; Sore throat; This is a spontaneous report from a contactable consumer reporting for herself. A 26-years-old female patient  received  bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on an unknown date in Dec2020 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  There were no concomitant medications.  The patient stated she got the first Pfizer Covid vaccine and on an unknown date in Dec2020 she tested positive for Covid 19, she also experienced nasal congestion and sore throat. The outcome of the events is unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Headache, Vaccination site pain
Clinical narrative: Mild pain at the injection site the next day; Mild headache within 1-2 hours of injection; Mild headache within 1-2 hours of injection; This is a spontaneous report received from a contactable physician (who is also the patient). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH 9899), via an unspecified route of administration in left arm on 18Dec2020 13:15 at single dose for COVID-19 immunization. Medical history included history of headaches and dyslipidemia. The patient has no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced mild headache within 1-2 hours of injection on 18Dec2020 and mild pain at the injection site the next day on 19Dec2020. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Dec2020 (reported as "resolved within 24-48 hours"). The reporter assessed the report as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ON RIGHT ARM
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pharyngeal swelling
Clinical narrative: anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization.  Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020.  The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events.    Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions.  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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Limb discomfort, Neck pain, Pain
Clinical narrative: patient described left arm pain that radiates up his arm and into his neck and that he couldn't continue to work the rest of the day on 1/6/21.  recommended that he use ibuprofen for muscle pain and to contact his provider if symptoms increase
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: the patient experienced tinnitus; This is a spontaneous report from a contactable pharmacist. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Dec2020 at single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient experienced tinnitus (tinnitus) on Dec2020 after receiving the vaccine. The patient went to see his doctor, but no cause for the tinnitus was identified. No treatment for the tinnitus was administered. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Electrocardiogram, Fatigue, Headache
Clinical narrative: Received the vaccine around 9:15 pm PST. Arrived home and went to sleep. Around 11:15 PM PST, was awoken with extreme chest pains, nausea, and headache. Attempted to get up to get to the bathroom, and was unable to make it there prior to fainintng. Was able to come to cognitively but was unable to move or get up. Had an overwhelming feeling of extreme muscle weakness. Was getting muscles spasms in the legs and extreme fatigue. Husband was able to get her up and dressed and took her to ER for a full work up. Was there from 12-3am PST.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Received the vaccine around 9:15 pm PST. Arrived home and went to sleep. Around 11:15 PM PST, was awoken with extreme chest pains, nausea, and headache. Attempted to get up to get to the bathroom, and was unable to make it there prior to fainintng. Was able to come to cognitively but was unable to move or get up. Had an overwhelming feeling of extreme muscle weakness. Was getting muscles spasms in the legs and extreme fatigue. Husband was able to get her up and dressed and took her to ER for a full work up. Was there from 12-3am PST.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Received the vaccine around 9:15 pm PST. Arrived home and went to sleep. Around 11:15 PM PST, was awoken with extreme chest pains, nausea, and headache. Attempted to get up to get to the bathroom, and was unable to make it there prior to fainintng. Was able to come to cognitively but was unable to move or get up. Had an overwhelming feeling of extreme muscle weakness. Was getting muscles spasms in the legs and extreme fatigue. Husband was able to get her up and dressed and took her to ER for a full work up. Was there from 12-3am PST.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Blood pressure decreased, Feeling cold, Heart rate increased, Paraesthesia
Clinical narrative: she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and 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 the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision
Clinical narrative: she got tunnel vision; almost passed out; Blood pressure dropped to 70/50; heart rate went up to 140; whole body got cold and tingly; whole body got cold and tingly; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biotech; lot number: EL0142) via an unspecified route of administration at left arm on 30Dec2020 at 12:45 PM at a single dose (dose number: 1) for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included premature ventricular contractions (PVCs). No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. No other vaccine in four weeks and no other medications in two weeks. The patient experienced adverse events included blood pressure dropped to 70/50, heart rate went up to 140, whole body got cold and tingly and she got tunnel vision and almost passed out. The events all started on 30Dec2020 at 12:45 PM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19, and 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 the close temporal relationship, the association between the event tunnel vision with BNT162b2 can not be fully 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Headache, Injection site pain, Malaise
Clinical narrative: The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. "Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on temporal relationship.  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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: The body aches started in his shoulder and now are all over his neck, back and whole body aches; The body aches started in his shoulder and now are all over his neck, back and whole body aches/ feeling like he has 1,000 pounds on his back; The body aches started in his shoulder and now are all over his neck, back and whole body aches; Body aches/The body aches started in his shoulder and now are all over his neck, back and whole body aches; Headache; Chills; Feel like crap; Low grade temperature; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL0142) intramuscularly at right shoulder approximately at 17:30 on 29Dec2020 for Covid-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity (a little over weight but he is fit). The patient had COVID in the end of Apr2020. The patient had no family medical history and had no prior vaccinations within four weeks. The patient had no concomitant medication. The second day of the vaccination, the patient called to report body aches, headache, chills, low grade temperature. As he reported, he just woke up and was walking around feeling like he had 1000 pounds on his back and felt like crap. The body aches started in his shoulder and currently all over his neck, back and whole body aches. Chills started last night (vaccination night). He was just trying to get to sleep and had to put an extra sweatshirt on last night. He did not check his temperature until he got up and it was 99.2 degrees Fahrenheit. He was not able to provide a start date for the temperature. "Body aches, headache between, chills between, low grade temperature (unspecified start date), feels like crap" were considered developing between 24:00-01:00. He stated that they were all medically significant and he needs a day to recover hopefully. He just felt like he was hit by a truck. The patient had not visited physician or went to ER yet. The outcome of low grade temperature was unknown, chills was resolving and all other events did not resolve at the time of reporting.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain, headache, chills, and pyrexia were related to BNT162b2 based on known drug safety profile. The association between the other reported events with BNT162b2 can not be completely excluded based on temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dry mouth, Fatigue, Headache
Clinical narrative: severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral pain, Pain, Retching
Clinical narrative: severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Myocardial infarction
Clinical narrative: A nurse got Bell's Palsy after the vaccine; heart attack; This is a spontaneous report from a contactable consumer. A female patient (nurse) of an unspecified age received single dose of BNT162B2 (batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The consumer asked if Pfizer have more information if so then what's the ingredients. States that "injury lawyers know how many deaths because of the vaccine. Bell's palsy, a nurse got Bell Palsy after the vaccine, she is all distorted, and 30 days later, that's the 2nd one to have a heart attack." The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 2nd one to have a heart attack; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. After stating Pfizer has submitted a request for Emergency Use Authorization for potential COVID-19 vaccine and it was now in the FDA's hands, the reporter inquired if Pfizer had more information if so then what's the ingredients. It was then reported that the patient's the 2nd one to have a heart attack on an unspecified date. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: The association between the event heart attack 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: On 12/28/2020 around 9 PM she started feeling fatigued.  Also noticed L arm tenderness at this time. This has continued since this time..  She knew it has been sore, hurting and swollen. Yesterday 1/5/2021, she had her daughter look at site and take pictures, she was able to see redness and she could feel heat radiating from this. She went to urgent care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: On 12/28/2020 around 9 PM she started feeling fatigued.  Also noticed L arm tenderness at this time. This has continued since this time..  She knew it has been sore, hurting and swollen. Yesterday 1/5/2021, she had her daughter look at site and take pictures, she was able to see redness and she could feel heat radiating from this. She went to urgent care.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Facial paralysis, Hypoaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient.  A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination.  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 previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing.   On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis 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: F
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral
Clinical narrative: edema started in her feet and ankles and then moved 3 quarter way to her shin; 4+ pitting edema; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she received the Covid vaccine on 17Dec2020 and on 25Dec2020 she noticed her shoes were snug and on 26Dec2020 she noticed 4+ pitting edema lasting 3 days. She went and brought some compression stockings and this has helped the edema improve but was still mild. The edema started in her feet and ankles and then moved 3 quarter way to her shin. She would like to know if she should receive second dose of Pfizer vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; 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, COVID19
Symptoms: Oedema, Oedema peripheral
Clinical narrative: edema started in her feet and ankles and then moved 3 quarter way to her shin; 4+ pitting edema; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported she received the Covid vaccine on 17Dec2020 and on 25Dec2020 she noticed her shoes were snug and on 26Dec2020 she noticed 4+ pitting edema lasting 3 days. She went and brought some compression stockings and this has helped the edema improve but was still mild. The edema started in her feet and ankles and then moved 3 quarter way to her shin. She would like to know if she should receive second dose of Pfizer vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; 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: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Throat clearing, Throat tightness
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Throat clearing, Throat tightness
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Anxiety, Chest X-ray normal, Condition aggravated, Electrocardiogram P wave abnormal
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram QRS complex normal, Electrocardiogram QT prolonged, Fibrin D dimer normal, Heart rate increased, Hypersensitivity
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Panic attack, Sinus tachycardia, Tachycardia, Throat tightness, Troponin normal
Clinical narrative: Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea 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.