chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Metabolic function test, Pharyngeal erythema, Pharyngeal swelling, Platelet count
Clinical narrative: anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Right arm on 05Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included reported as none. Concomitant medications included methylprednisolone (MEDROL DOSEPAK), cetirizine hydrochloride (ZYRTEC), docusate sodium, sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EK5730) on 16Dec2020 15:45 at right arm for covid-19 immunization. The patient experienced anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy on 06Jan2021 07:00. Event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days of the hospitalization was reported as 2. Treatment received for the events included: Prednisone, solu-medrol, Pepcid, Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab/Respiratory Pathogen panel with COVID-19: negative on 28Jan2021. The outcome of the event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on known safety profile of suspect drug and 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Swollen tongue
Clinical narrative: anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Right arm on 05Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included reported as none. Concomitant medications included methylprednisolone (MEDROL DOSEPAK), cetirizine hydrochloride (ZYRTEC), docusate sodium, sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EK5730) on 16Dec2020 15:45 at right arm for covid-19 immunization. The patient experienced anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy on 06Jan2021 07:00. Event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days of the hospitalization was reported as 2. Treatment received for the events included: Prednisone, solu-medrol, Pepcid, Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab/Respiratory Pathogen panel with COVID-19: negative on 28Jan2021. The outcome of the event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on known safety profile of suspect drug and 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Lethargy, Peripheral swelling, Pharyngeal swelling, SARS-CoV-2 test negative
Clinical narrative: anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Right arm on 05Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included reported as none. Concomitant medications included methylprednisolone (MEDROL DOSEPAK), cetirizine hydrochloride (ZYRTEC), docusate sodium, sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EK5730) on 16Dec2020 15:45 at right arm for covid-19 immunization. The patient experienced anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy on 06Jan2021 07:00. Event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days of the hospitalization was reported as 2. Treatment received for the events included: Prednisone, solu-medrol, Pepcid, Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab/Respiratory Pathogen panel with COVID-19: negative on 28Jan2021. The outcome of the event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on known safety profile of suspect drug and 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: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Syncope, Urticaria
Clinical narrative: anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration at Right arm on 05Jan2021 16:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient was not pregnant. Medical history included reported as none. Concomitant medications included methylprednisolone (MEDROL DOSEPAK), cetirizine hydrochloride (ZYRTEC), docusate sodium, sertraline hydrochloride (ZOLOFT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EK5730) on 16Dec2020 15:45 at right arm for covid-19 immunization. The patient experienced anaphylactic reaction including throat swelling, face, hand and feet swelling, hives, tongue swelling, fainting, lethargy on 06Jan2021 07:00. Event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days of the hospitalization was reported as 2. Treatment received for the events included: Prednisone, solu-medrol, Pepcid, Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab/Respiratory Pathogen panel with COVID-19: negative on 28Jan2021. The outcome of the event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on known safety profile of suspect drug and 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: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypertension, Swollen tongue, Throat irritation, Throat tightness
Clinical narrative: headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin.  Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Tongue pruritus, X-ray
Clinical narrative: headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin.  Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Investigation
Clinical narrative: headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin.  Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Tachycardia, Throat irritation
Clinical narrative: headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin.  Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Paraesthesia oral, Throat clearing, Throat irritation, Tinnitus
Clinical narrative: headache; dizziness; lack of appetite; extreme fatigue; tachycardia; swollen tongue; scratchy throat; This is a spontaneous report from a contactable other hcp. A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 08Jan2021 16:00 on Left arm at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, sero negative RA, Known allergies: Penicillin.  Concomitant medication included amlodipine (AMLODIPINE). No covid prior vaccination. No other vaccine in four weeks. Adverse event: Initially the patient got tachycardia, swollen tongue and scratchy throat 08Jan2021 16:15. Next day (09Jan2021) extreme fatigue, headache, dizziness, lack of appetite. 10 days later, was still not better. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. AE treatment included: Prednisone, 40 mg for 5 days, Benadryl 25 mg 2 x d. Covid test type post vaccination (Nasal Swab) on 13Jan2021 and 15Jan2021, was negative. The event outcome was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: patient tested positive for covid virus; patient tested positive for covid virus; This is a spontaneous report from a contactable consumer (patient), received via a Pfizer-sponsored program. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 13Jan2021, the patient tested positive for covid virus. The patient would like to know about getting the second dose of vaccine. Outcome of the event was unknown.   Information about Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient tested positive for covid virus; patient tested positive for covid virus; This is a spontaneous report from a contactable consumer (patient), received via a Pfizer-sponsored program. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 13Jan2021, the patient tested positive for covid virus. The patient would like to know about getting the second dose of vaccine. Outcome of the event was unknown.   Information about Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Palpitations
Clinical narrative: About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac flutter, Cardiac monitoring, Electrocardiogram, Extrasystoles
Clinical narrative: About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Palpitations
Clinical narrative: About 10 minutes after I received the vaccine I felt my heart flutter. At the time I didn't think anything of it but the flutter continued and felt like my heart was skipping a beat. This continued the next day (Friday) so I reached out to my doctor. She placed me on a Beta Blocker which reduced the number of palpitations. Today is 4 weeks since I had my first dose of the vaccine and I am still feeling my heart flutter.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Pruritus
Clinical narrative: Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of head, forehead, and eye; Cluster headaches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1686) via an unspecified route of administration in the left arm on 08Jan2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included migraines. Concomitant medications included magnesium, vitamin B12 and vitamins NOS (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin sulfate/polymyxin b sulfate (NEOSPORIN) and experienced allergy. On 08Jan2021 at 20:00, the patient experienced allergic reaction, itchiness on right side of head, forehead, and eye and cluster headaches. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and sumatriptan. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cluster headache, Eye pruritus, Hypersensitivity, Pruritus
Clinical narrative: Allergic reaction; Itchiness on right side of head, forehead, and eye; Itchiness on right side of head, forehead, and eye; Cluster headaches; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1686) via an unspecified route of administration in the left arm on 08Jan2021 at 11:00 at single dose for COVID-19 immunisation. The patient was not pregnant. Relevant medical history included migraines. Concomitant medications included magnesium, vitamin B12 and vitamins NOS (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took neomycin sulfate/polymyxin b sulfate (NEOSPORIN) and experienced allergy. On 08Jan2021 at 20:00, the patient experienced allergic reaction, itchiness on right side of head, forehead, and eye and cluster headaches. The events resulted in Doctor or other healthcare professional office/clinic visit. Corrective treatments taken as a result of the events included diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID) and sumatriptan. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with sequel from the events on an unspecified date.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: 13 minutes into the vaccination she developed rash on her neck and face that was itchy. She was given epinephrine and IM diphenhydramine. She was sent to the ED where upon arrival she developed throat tightness and difficulty in swallowing. She was given solumedrol in the ED and observed. She did well on therapy
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Rash, Rash pruritic, Throat tightness, Tryptase
Clinical narrative: 13 minutes into the vaccination she developed rash on her neck and face that was itchy. She was given epinephrine and IM diphenhydramine. She was sent to the ED where upon arrival she developed throat tightness and difficulty in swallowing. She was given solumedrol in the ED and observed. She did well on therapy
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypertension, Pyrexia
Clinical narrative: Within 5 minutes, I felt weird and light headed.  My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic.  I was on the antibiotic 1/26 - 1/30.  Today is 2/4 and I'm still coughing.   Something weird also happened, smells changed.  My coffee smelled awful and other things seemed extremely strong.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Body temperature increased, Cough, Dizziness, Fatigue
Clinical narrative: Within 5 minutes, I felt weird and light headed.  My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic.  I was on the antibiotic 1/26 - 1/30.  Today is 2/4 and I'm still coughing.   Something weird also happened, smells changed.  My coffee smelled awful and other things seemed extremely strong.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Within 5 minutes, I felt weird and light headed.  My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic.  I was on the antibiotic 1/26 - 1/30.  Today is 2/4 and I'm still coughing.   Something weird also happened, smells changed.  My coffee smelled awful and other things seemed extremely strong.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Productive cough, Rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Within 5 minutes, I felt weird and light headed.  My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic.  I was on the antibiotic 1/26 - 1/30.  Today is 2/4 and I'm still coughing.   Something weird also happened, smells changed.  My coffee smelled awful and other things seemed extremely strong.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Within 5 minutes, I felt weird and light headed.  My blood pressure spiked, temperature spiked to 101, heart rate was elevated and continued to be elevated for about 12 hours, and there was a rash across my chest and upper arms. On 1/14, I was extremely tired. On 1/15, I had a sore throat, headache, and still slightly tired. As the days went on, the cold symptoms got progressive worse. Extremely congested, runny nose, extremely painful headache, coughing up pflegm, sore throat, etc. On Wednesday, 1/20 I had a fever of 101. I had these cold symptoms for a week and a half and that was when I called my doctor. She gave me an antibiotic.  I was on the antibiotic 1/26 - 1/30.  Today is 2/4 and I'm still coughing.   Something weird also happened, smells changed.  My coffee smelled awful and other things seemed extremely strong.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: This incident was a documentation error. During clinic, the vaccinator documented that the patient received Moderna for 2nd dose, even though previous records confirmed that the pt received Pfizer for 1st dose. However, pt confirmed that she received a blue sheet of paper (which in our clinic workflow means Pfizer dose) and that her CDC Immunization Card is labeled as Pfizer for 2nd dose on 1/11. Vaccinator also confirmed that she only provided Pfizer immunizations for the entire day, and that she is not comfortable/experienced with using an iPad. Thus, it is highly likely that this was purely a documentation error and the patient correctly received the Pfizer vaccine for both doses.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination error
Clinical narrative: This incident was a documentation error. During clinic, the vaccinator documented that the patient received Moderna for 2nd dose, even though previous records confirmed that the pt received Pfizer for 1st dose. However, pt confirmed that she received a blue sheet of paper (which in our clinic workflow means Pfizer dose) and that her CDC Immunization Card is labeled as Pfizer for 2nd dose on 1/11. Vaccinator also confirmed that she only provided Pfizer immunizations for the entire day, and that she is not comfortable/experienced with using an iPad. Thus, it is highly likely that this was purely a documentation error and the patient correctly received the Pfizer vaccine for both doses.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Patient likely received mixed vaccines for her COVID-19 vaccination series, Pfizer for 1st dose and Moderna for 2nd dose. Pt received Pfizer for 1st dose on 12/19/2020 (lot # EK5730). This report is for 2nd dose.  For 2nd dose on 1/11/21, she confirmed receiving green piece of paper (which indicates Moderna dose in our clinic workflow), and her CDC immunization card also states Moderna 2nd dose. During f/u with patient 1/15/21, pt did not report any s/sx or ADRs other than sore arm.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Interchange of vaccine products, No adverse event
Clinical narrative: Patient likely received mixed vaccines for her COVID-19 vaccination series, Pfizer for 1st dose and Moderna for 2nd dose. Pt received Pfizer for 1st dose on 12/19/2020 (lot # EK5730). This report is for 2nd dose.  For 2nd dose on 1/11/21, she confirmed receiving green piece of paper (which indicates Moderna dose in our clinic workflow), and her CDC immunization card also states Moderna 2nd dose. During f/u with patient 1/15/21, pt did not report any s/sx or ADRs other than sore arm.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Paraesthesia, Swollen tongue
Clinical narrative: Tongue swollen roof of mouth tingling metallic taste
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue swollen roof of mouth tingling metallic taste
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Skin warm
Clinical narrative: numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face feels numb; This is a spontaneous report from a contactable consumer reporting for self. This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) on 18Jan2021 09:00 at single dose (Anatomical location: upper left arm) for COVID-19 immunisation. Medical history included penicillin allergic when she was a teenager, and allergic to cephlasporins. Ongoing concomitant medications included omeprazole, vitamin d nos (VITAMIN D) and birth control pills. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. Patient said she had a reaction to the 1st dose of the vaccine. She said that she felt fine in first 15 minutes after the vaccine, about 30 minutes later, she experienced numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face felt numb, facial numbness on left side of her face but no paralysis. She stated she was able to move her face. The event onset time reported as 09:40 on 18Jan2021. Stated it felt like she went to the dentist and got a numbing shot like it was starting to wear off.  Patient wanted to know if that is a typical reaction, and if it is related to Bell's palsy. Treatment was received for the event, patient just took Turmeri 1 table. No hospitalization involved, the event did not require a visit to emergency room or physician office. The outcome of event was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face feels numb; This is a spontaneous report from a contactable consumer reporting for self. This 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) on 18Jan2021 09:00 at single dose (Anatomical location: upper left arm) for COVID-19 immunisation. Medical history included penicillin allergic when she was a teenager, and allergic to cephlasporins. Ongoing concomitant medications included omeprazole, vitamin d nos (VITAMIN D) and birth control pills. No additional vaccines administered on same date of the BNT162B2. No prior vaccinations within 4 weeks. Patient said she had a reaction to the 1st dose of the vaccine. She said that she felt fine in first 15 minutes after the vaccine, about 30 minutes later, she experienced numbness on her temple, which moved down to her left cheek on her ear area. She also said that the side of her face felt numb, facial numbness on left side of her face but no paralysis. She stated she was able to move her face. The event onset time reported as 09:40 on 18Jan2021. Stated it felt like she went to the dentist and got a numbing shot like it was starting to wear off.  Patient wanted to know if that is a typical reaction, and if it is related to Bell's palsy. Treatment was received for the event, patient just took Turmeri 1 table. No hospitalization involved, the event did not require a visit to emergency room or physician office. The outcome of event was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Diarrhoea, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feeling very dizzy; off balance and felt as if she will fall while walking; Diarrhea; Felt heavy at the back of head; Neck pains; small bout of vertigo when she laid in the bed; Very tired; Brain fog; This is a spontaneous report from a contactable nurse who reported for herself. A 35-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EJ1686) intramuscularly at left arm, 11:30 AM on 05Jan2021 for Covid-19 immunization. The patient had no medical history and had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Approximately two hours after the shot (01:30 PM), patient started feeling very dizzy, off balance and felt as if she will fall while walking, had diarrhea, felt heavy at the back of her head and had neck pains. She had small bout of vertigo when she laid in the bed and she felt very tired and had some brain fog. The symptoms improved in 12 hours. No treatment was received for the events. The events resolved at last observation. 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 asked that should she take the 2nd dose.  The patient considered that all events were non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Neck pain, Vertigo
Clinical narrative: Feeling very dizzy; off balance and felt as if she will fall while walking; Diarrhea; Felt heavy at the back of head; Neck pains; small bout of vertigo when she laid in the bed; Very tired; Brain fog; This is a spontaneous report from a contactable nurse who reported for herself. A 35-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EJ1686) intramuscularly at left arm, 11:30 AM on 05Jan2021 for Covid-19 immunization. The patient had no medical history and had no known allergies. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Approximately two hours after the shot (01:30 PM), patient started feeling very dizzy, off balance and felt as if she will fall while walking, had diarrhea, felt heavy at the back of her head and had neck pains. She had small bout of vertigo when she laid in the bed and she felt very tired and had some brain fog. The symptoms improved in 12 hours. No treatment was received for the events. The events resolved at last observation. 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 asked that should she take the 2nd dose.  The patient considered that all events were non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysarthria, Feeling abnormal, Mydriasis
Clinical narrative: slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Feeling abnormal
Clinical narrative: slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp.  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysarthria, Feeling abnormal, Mydriasis
Clinical narrative: she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and the lower part of her legs got swollen and really red, almost purply red. Patient went to see the doctor two days later to confirm about a blood clot so they did check her for a blood clot, and she didn't have one but it was kind of like a thrombosis kind of thing and was put on antibiotics for that. After the patient took the second dose of vaccine, she was sitting in her office trying to work and she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog. It was kind of like the feeling of being drugged. She couldn't make herself do anything. She couldn't think, she could feel herself hearing people talk but couldn't respond correctly, couldn't speak quickly, she was talking really slow. She was assisted by a doctor and told her that she needs to go to the ER. She thinks they were afraid she was getting ready to have a stroke or something. So, she went to the ER and while she was sitting in the ER it kind of started to go away and she was coming back to herself. They went ahead and did a CT and everything was okay. The outcome of the event "she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog" was recovering.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Feeling abnormal
Clinical narrative: she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported) on an unspecified date for COVID-19 immunization and the lower part of her legs got swollen and really red, almost purply red. Patient went to see the doctor two days later to confirm about a blood clot so they did check her for a blood clot, and she didn't have one but it was kind of like a thrombosis kind of thing and was put on antibiotics for that. After the patient took the second dose of vaccine, she was sitting in her office trying to work and she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog. It was kind of like the feeling of being drugged. She couldn't make herself do anything. She couldn't think, she could feel herself hearing people talk but couldn't respond correctly, couldn't speak quickly, she was talking really slow. She was assisted by a doctor and told her that she needs to go to the ER. She thinks they were afraid she was getting ready to have a stroke or something. So, she went to the ER and while she was sitting in the ER it kind of started to go away and she was coming back to herself. They went ahead and did a CT and everything was okay. The outcome of the event "she couldn't work, she couldn't function. It was like she was two steps behind she was in a brain fog" was recovering.    Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient got her Covid-19 vaccine around 8:00 AM  on 1/19/21. Around 10:00 AM  patient presented at urgent care clinic. Reported  red spots on her neck, face and chest. Patient also have throat discomfort, feels like she needs an extra effort to breath.  Benadryl 25 mg po given per MD order.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oropharyngeal discomfort, Rash, Rash erythematous
Clinical narrative: Patient got her Covid-19 vaccine around 8:00 AM  on 1/19/21. Around 10:00 AM  patient presented at urgent care clinic. Reported  red spots on her neck, face and chest. Patient also have throat discomfort, feels like she needs an extra effort to breath.  Benadryl 25 mg po given per MD order.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Plasmapheresis
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report from a contactable consumer. A female patient (sister) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very serious adverse event that now had Guillain Barre syndrome. She was hospitalized 6 days ago. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram spine, Dysstasia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report from a contactable consumer. A female patient (sister) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very serious adverse event that now had Guillain Barre syndrome. She was hospitalized 6 days ago. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lumbar puncture, Magnetic resonance imaging brain, Muscular weakness, Plasmapheresis
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report from a contactable consumer. A female patient (sister) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very serious adverse event that now had Guillain Barre syndrome. She was hospitalized 6 days ago. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia oral, Lumbar puncture
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report from a contactable consumer. A female patient (sister) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very serious adverse event that now had Guillain Barre syndrome. She was hospitalized 6 days ago. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report from a contactable consumer. A female patient (sister) of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a very serious adverse event that now had Guillain Barre syndrome. She was hospitalized 6 days ago. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.