chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tonque deviated to the Left; R hand and forearm in a radial distribution started having parasthesias/ thigh tingingly/ groin tingingly; L face has been mildly numb, then to both lateral feet L > R; bilat feet burning/planter feet sore and burning; Left abd fasiculations, now some in low back and random places; fatigued calfs/lower legs the most bothered; planter feet sore and burning; leg weakness; decreased exercise tolerance; This is a spontaneous report from a contactable physician. A 52-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: FL3247), on Arm Right intramuscular from 21Jan2021 15:00 at single dose for covid-19 immunisation. Medical history included low testosterone low testosterone, othewise very healthy, athletic, exercises at high level. Concomitant medication included testosterone (topical). It was reported that thee hrs after vaccine, my R hand and forearm in a radial distribution started having parasthesias. this continued. Following day L face has been mildly numb, then to both lateral feet L > R, within 5days my tonque deviated to the Left. he reported this to VEARS online and 2 phone calls with no reply. then to my work, and to the (Group Name) giving vaccine things have progressed to bilat feet burning, thigh tingingly, groin tinginly, Left abd fasiculations, now some in low back and random places.. lower legs the most bothered, fatigued calfs, planter feet sore and burning, concern for lower leg weakness, new decreased exercise tolerance, went to ER have had labs, MRI, and now seeing neurologist he have been trying to get help for weeks, and finally my work gave me this site he just canceled my 2nd shot for yesterday -that was easy decison, he need these symptoms to go away, awaiting battery of labs, and possibly an LP - u/s guided in radiology. Outcome of the events was not recovered.; Sender's Comments: Considering close temporal relationship, a possible contributory role of suspect product bnt162b2 to the reported 'tongue deviated to the Left' cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: tonque deviated to the Left; R hand and forearm in a radial distribution started having parasthesias/ thigh tingingly/ groin tingingly; L face has been mildly numb, then to both lateral feet L > R; bilat feet burning/planter feet sore and burning; Left abd fasiculations, now some in low back and random places; fatigued calfs/lower legs the most bothered; planter feet sore and burning; leg weakness; decreased exercise tolerance; This is a spontaneous report from a contactable physician. A 52-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: FL3247), on Arm Right intramuscular from 21Jan2021 15:00 at single dose for covid-19 immunisation. Medical history included low testosterone low testosterone, othewise very healthy, athletic, exercises at high level. Concomitant medication included testosterone (topical). It was reported that thee hrs after vaccine, my R hand and forearm in a radial distribution started having parasthesias. this continued. Following day L face has been mildly numb, then to both lateral feet L > R, within 5days my tonque deviated to the Left. he reported this to VEARS online and 2 phone calls with no reply. then to my work, and to the (Group Name) giving vaccine things have progressed to bilat feet burning, thigh tingingly, groin tinginly, Left abd fasiculations, now some in low back and random places.. lower legs the most bothered, fatigued calfs, planter feet sore and burning, concern for lower leg weakness, new decreased exercise tolerance, went to ER have had labs, MRI, and now seeing neurologist he have been trying to get help for weeks, and finally my work gave me this site he just canceled my 2nd shot for yesterday -that was easy decison, he need these symptoms to go away, awaiting battery of labs, and possibly an LP - u/s guided in radiology. Outcome of the events was not recovered.; Sender's Comments: Considering close temporal relationship, a possible contributory role of suspect product bnt162b2 to the reported 'tongue deviated to the Left' cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: tonque deviated to the Left; R hand and forearm in a radial distribution started having parasthesias/ thigh tingingly/ groin tingingly; L face has been mildly numb, then to both lateral feet L > R; bilat feet burning/planter feet sore and burning; Left abd fasiculations, now some in low back and random places; fatigued calfs/lower legs the most bothered; planter feet sore and burning; leg weakness; decreased exercise tolerance; This is a spontaneous report from a contactable physician. A 52-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: FL3247), on Arm Right intramuscular from 21Jan2021 15:00 at single dose for covid-19 immunisation. Medical history included low testosterone low testosterone, othewise very healthy, athletic, exercises at high level. Concomitant medication included testosterone (topical). It was reported that thee hrs after vaccine, my R hand and forearm in a radial distribution started having parasthesias. this continued. Following day L face has been mildly numb, then to both lateral feet L > R, within 5days my tonque deviated to the Left. he reported this to VEARS online and 2 phone calls with no reply. then to my work, and to the (Group Name) giving vaccine things have progressed to bilat feet burning, thigh tingingly, groin tinginly, Left abd fasiculations, now some in low back and random places.. lower legs the most bothered, fatigued calfs, planter feet sore and burning, concern for lower leg weakness, new decreased exercise tolerance, went to ER have had labs, MRI, and now seeing neurologist he have been trying to get help for weeks, and finally my work gave me this site he just canceled my 2nd shot for yesterday -that was easy decison, he need these symptoms to go away, awaiting battery of labs, and possibly an LP - u/s guided in radiology. Outcome of the events was not recovered.; Sender's Comments: Considering close temporal relationship, a possible contributory role of suspect product bnt162b2 to the reported 'tongue deviated to the Left' cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety
Clinical narrative: vomiting; diarrhea; weak; tired; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting, diarrhea, weak, and tired in Feb2021. It was reported that the patient had trouble in her stomach a week before reporting (vomiting, diarrhea, weak, tired). The clinical outcome of vomiting, diarrhea, weak, and tired was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Vomiting
Clinical narrative: vomiting; diarrhea; weak; tired; This is a spontaneous report from a contactable consumer (patient) from a sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting, diarrhea, weak, and tired in Feb2021. It was reported that the patient had trouble in her stomach a week before reporting (vomiting, diarrhea, weak, tired). The clinical outcome of vomiting, diarrhea, weak, and tired was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Muscle tightness, Pallor, Rash, Swelling
Clinical narrative: Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; This is a spontaneous report from a contactable Nurse. This 65-year-old female Nurse (patient) reported that she started to receive bnt162b2 (BNT162B2, Solution for injection, Lot# EL9265), via an unspecified route of administration from 29Jan2021 10:30 to 29Jan2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergy to venom from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), calcium (CALCIUM), lisinopril (LISINOPRIL), omeprazole (PRILOSEC [OMEPRAZOLE]). On 29Jan2021 10:45 the patient experienced rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck, rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovering. Therapeutic measures were taken as a result of rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; This is a spontaneous report from a contactable Nurse. This 65-year-old female Nurse (patient) reported that she started to receive bnt162b2 (BNT162B2, Solution for injection, Lot# EL9265), via an unspecified route of administration from 29Jan2021 10:30 to 29Jan2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergy to venom from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), calcium (CALCIUM), lisinopril (LISINOPRIL), omeprazole (PRILOSEC [OMEPRAZOLE]). On 29Jan2021 10:45 the patient experienced rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck, rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovering. Therapeutic measures were taken as a result of rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Pruritus, Rash, Swelling face
Clinical narrative: Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; This is a spontaneous report from a contactable Nurse. This 65-year-old female Nurse (patient) reported that she started to receive bnt162b2 (BNT162B2, Solution for injection, Lot# EL9265), via an unspecified route of administration from 29Jan2021 10:30 to 29Jan2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergy to venom from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), calcium (CALCIUM), lisinopril (LISINOPRIL), omeprazole (PRILOSEC [OMEPRAZOLE]). On 29Jan2021 10:45 the patient experienced rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck, rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovering. Therapeutic measures were taken as a result of rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness).
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: BLOOD CLOT (RMCA) ISCHEMIC STROKE, INABILITY TO SWALLOW, IMPAIRED MOVEMENT (LEFT SIDE)  MULTIPLE FAILED SWALLOW TESTS, TWO CT SCANS IN HOSPITAL (NO CHANGE)  IMPAIRMENT SEVERE (DID NOT QUALIFY FOR REHAB), REFERRED BY PHYSICIAN TO HOSPICE. IN HOSPICE 01/30/2021 - DOD 02/06/2021
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Barium swallow abnormal, Computerised tomogram, Dysphagia, Ischaemic stroke, Movement disorder
Clinical narrative: BLOOD CLOT (RMCA) ISCHEMIC STROKE, INABILITY TO SWALLOW, IMPAIRED MOVEMENT (LEFT SIDE)  MULTIPLE FAILED SWALLOW TESTS, TWO CT SCANS IN HOSPITAL (NO CHANGE)  IMPAIRMENT SEVERE (DID NOT QUALIFY FOR REHAB), REFERRED BY PHYSICIAN TO HOSPICE. IN HOSPICE 01/30/2021 - DOD 02/06/2021
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT (RMCA) ISCHEMIC STROKE, INABILITY TO SWALLOW, IMPAIRED MOVEMENT (LEFT SIDE)  MULTIPLE FAILED SWALLOW TESTS, TWO CT SCANS IN HOSPITAL (NO CHANGE)  IMPAIRMENT SEVERE (DID NOT QUALIFY FOR REHAB), REFERRED BY PHYSICIAN TO HOSPICE. IN HOSPICE 01/30/2021 - DOD 02/06/2021
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269)  to reported events cannot totally be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269)  to reported events cannot totally be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chest discomfort, Chills
Clinical narrative: Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269)  to reported events cannot totally be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate, Oxygen saturation, Pyrexia, Respiratory rate
Clinical narrative: Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269)  to reported events cannot totally be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Feverish/Temp (Body temperature) 99.2; chilled feeling; Right chest tightness; Dizziness; Ringing in ears; BP (Blood pressure) 136/88; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269) intramuscularly on 03Feb2021 01:30 PM at single dose in left arm for COVID-19 immunization at School or Student Health Clinic. Medical history included Anxiety/depression. Allergies to medications, food, or other products included Lamictal and Coconut. The patient was not pregnant at time of vaccination. The other medications patient received included birth control within 2 weeks of vaccination. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was feverish but along with chilled feeling, also experienced right chest tightness, dizziness and ringing in ears on 03Feb2021. Adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events was reported as yes, will go to urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient had labs and procedures included Temp (Body temperature) 99.2; BP (Blood pressure) 136/88; HR (Heart rate) 81; RR (Respiratory rate) 15; Oxygen 100% on 03Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9269)  to reported events cannot totally be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling, Throat tightness
Clinical narrative: After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; This is a spontaneous report from a contactable nurse.  This 37-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN9581), into the right arm on 08Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included hypothyroidism, gerd, depression, pcos. The patient had known allergies to sulpha and Ceclor. Concomitant drugs were unknown.  The nurse reported that she received vaccine on 08Feb2021, after waiting 15 minutes she was walking to her car and felt short of breath. Then she felt like her throat was tight and she couldn't swallow. The patient visited Emergency room/department or urgent care and was hospitalized. She was treated with Epinephrine x 3, Benadryl, steroids, famotidine. The outcome of the events was resolved with sequelae.; Sender's Comments: Based on available information, a contributory role of BNT162B2 vaccine can not be excluded for the reported events of short of breath, throat tight and swallow difficulty due to temporal relationship and current known drug safety profile.    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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; After waiting 15 minutes I was walking to my car and felt short of breath. Then I felt like my throat was tight and I couldn't swallow.; This is a spontaneous report from a contactable nurse.  This 37-year-old female nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN9581), into the right arm on 08Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included hypothyroidism, gerd, depression, pcos. The patient had known allergies to sulpha and Ceclor. Concomitant drugs were unknown.  The nurse reported that she received vaccine on 08Feb2021, after waiting 15 minutes she was walking to her car and felt short of breath. Then she felt like her throat was tight and she couldn't swallow. The patient visited Emergency room/department or urgent care and was hospitalized. She was treated with Epinephrine x 3, Benadryl, steroids, famotidine. The outcome of the events was resolved with sequelae.; Sender's Comments: Based on available information, a contributory role of BNT162B2 vaccine can not be excluded for the reported events of short of breath, throat tight and swallow difficulty due to temporal relationship and current known drug safety profile.    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: Arthralgia, Blood test normal, COVID-19, Chest X-ray normal, Chills
Clinical narrative: 20Jan2021 was first dose, positive covid test on 25Jan2021; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 20Jan2021 was first dose, positive covid test on 25Jan2021 second dose is scheduled for 10Feb2021, caller is wondering if and when she should have the second dose. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test positive, Weight decreased
Clinical narrative: 20Jan2021 was first dose, positive covid test on 25Jan2021; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 20Jan2021 was first dose, positive covid test on 25Jan2021 second dose is scheduled for 10Feb2021, caller is wondering if and when she should have the second dose. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 20Jan2021 was first dose, positive covid test on 25Jan2021; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 20Jan2021 was first dose, positive covid test on 25Jan2021 second dose is scheduled for 10Feb2021, caller is wondering if and when she should have the second dose. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Heart rate increased, Loss of consciousness
Clinical narrative: Patient passed out after getting the injection. Per RN, patient with Stridor.  37yo female presented to the UC and was pale with complaints of tightness in chest.  Heart rate up to 160s.  BP 114/83.  EKG shows sinus tachycardia at 116.  s/p anaphylactic versus vasovagal reaction to vaccine. Support the later consider vitals stable, no signs of angioedema/rash notes on examination. Possibly stridor at the tent, but patient notes she does recall starting to breathing heavy before loosing cautiousness. Patient was s/p epi pen x 2 (investigating if the pens fired properly) when presented to the UC. She was tachy and pale, but otherwise clinically was stable.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: Patient passed out after getting the injection. Per RN, patient with Stridor.  37yo female presented to the UC and was pale with complaints of tightness in chest.  Heart rate up to 160s.  BP 114/83.  EKG shows sinus tachycardia at 116.  s/p anaphylactic versus vasovagal reaction to vaccine. Support the later consider vitals stable, no signs of angioedema/rash notes on examination. Possibly stridor at the tent, but patient notes she does recall starting to breathing heavy before loosing cautiousness. Patient was s/p epi pen x 2 (investigating if the pens fired properly) when presented to the UC. She was tachy and pale, but otherwise clinically was stable.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Pallor, Presyncope, Sinus tachycardia
Clinical narrative: Patient passed out after getting the injection. Per RN, patient with Stridor.  37yo female presented to the UC and was pale with complaints of tightness in chest.  Heart rate up to 160s.  BP 114/83.  EKG shows sinus tachycardia at 116.  s/p anaphylactic versus vasovagal reaction to vaccine. Support the later consider vitals stable, no signs of angioedema/rash notes on examination. Possibly stridor at the tent, but patient notes she does recall starting to breathing heavy before loosing cautiousness. Patient was s/p epi pen x 2 (investigating if the pens fired properly) when presented to the UC. She was tachy and pale, but otherwise clinically was stable.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Immune thrombocytopenia, Intensive care, Platelet count decreased
Clinical narrative: Patient presented to the Emergency Department on 2/2/21 with black tarry stools and nose bleeds over the past few days and petechiae over past few weeks. Patient was found to have thrombocytopenia felt to be ITP. Patient platelets dropped from 230 on 01/10 to 4 on 02/01. Patient is currently not taking any blood thinners. Patients received dexamethasone on 2/2. Pt started on IVIG 50 gm daily x 4 days (total course ~ 2 gm/kg) on 2/3. Patient received tranexamic acid 1000 mg on 2/4 and 2/5, Romiplostim 500 mcg IV (~4.5 mcg/kg) on 2/5. (Continued on page 2)
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Epistaxis, Faeces discoloured, Immune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: Patient presented to the Emergency Department on 2/2/21 with black tarry stools and nose bleeds over the past few days and petechiae over past few weeks. Patient was found to have thrombocytopenia felt to be ITP. Patient platelets dropped from 230 on 01/10 to 4 on 02/01. Patient is currently not taking any blood thinners. Patients received dexamethasone on 2/2. Pt started on IVIG 50 gm daily x 4 days (total course ~ 2 gm/kg) on 2/3. Patient received tranexamic acid 1000 mg on 2/4 and 2/5, Romiplostim 500 mcg IV (~4.5 mcg/kg) on 2/5. (Continued on page 2)
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Melaena, Petechiae, Platelet count decreased, Platelet count normal, Platelet transfusion
Clinical narrative: Patient presented to the Emergency Department on 2/2/21 with black tarry stools and nose bleeds over the past few days and petechiae over past few weeks. Patient was found to have thrombocytopenia felt to be ITP. Patient platelets dropped from 230 on 01/10 to 4 on 02/01. Patient is currently not taking any blood thinners. Patients received dexamethasone on 2/2. Pt started on IVIG 50 gm daily x 4 days (total course ~ 2 gm/kg) on 2/3. Patient received tranexamic acid 1000 mg on 2/4 and 2/5, Romiplostim 500 mcg IV (~4.5 mcg/kg) on 2/5. (Continued on page 2)
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Patient presented to the Emergency Department on 2/2/21 with black tarry stools and nose bleeds over the past few days and petechiae over past few weeks. Patient was found to have thrombocytopenia felt to be ITP. Patient platelets dropped from 230 on 01/10 to 4 on 02/01. Patient is currently not taking any blood thinners. Patients received dexamethasone on 2/2. Pt started on IVIG 50 gm daily x 4 days (total course ~ 2 gm/kg) on 2/3. Patient received tranexamic acid 1000 mg on 2/4 and 2/5, Romiplostim 500 mcg IV (~4.5 mcg/kg) on 2/5. (Continued on page 2)
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, IVth nerve paralysis, Ophthalmological examination
Clinical narrative: Left Cranial Nerve 4 Palsy; double vision; This is a spontaneous report from a contactable consumer reported for himself. A 79-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the age of 79-year-old at arm left on 26Jan2021 01:30 PM at single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol. Concomitant medications in two weeks included amlodipine besilate, atorvastatin calcium (CADUET); dexlansoprazole (DEXILANT); clarithromycin (CLARITIN); clobetasol cream. There was no other vaccine in four weeks. There was no covid prior vaccination. On 09Feb2021, exactly 2 weeks to the day when he received the first dose of the vaccine, she woke up with double vision on 09Feb2021 08:00 AM which still persists. This was diagnosed as left cranial nerve 4 palsy. He had no prior history of double vision. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests included nasal swab: negative on 11Feb2021and Covid PCR test: negative on 11Feb2021. Therapeutic measures (Prism lens over left eye) were taken as a result of events. The outcome of event was not recovered.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, IVth nerve paralysis, SARS-CoV-2 test
Clinical narrative: Left Cranial Nerve 4 Palsy; double vision; This is a spontaneous report from a contactable consumer reported for himself. A 79-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the age of 79-year-old at arm left on 26Jan2021 01:30 PM at single dose for COVID-19 immunisation. Medical history included high blood pressure and elevated cholesterol. Concomitant medications in two weeks included amlodipine besilate, atorvastatin calcium (CADUET); dexlansoprazole (DEXILANT); clarithromycin (CLARITIN); clobetasol cream. There was no other vaccine in four weeks. There was no covid prior vaccination. On 09Feb2021, exactly 2 weeks to the day when he received the first dose of the vaccine, she woke up with double vision on 09Feb2021 08:00 AM which still persists. This was diagnosed as left cranial nerve 4 palsy. He had no prior history of double vision. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests included nasal swab: negative on 11Feb2021and Covid PCR test: negative on 11Feb2021. Therapeutic measures (Prism lens over left eye) were taken as a result of events. The outcome of event was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Pain, Pain in extremity
Clinical narrative: lymph node pain; pain under armpit of arm where vaccine was given; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number 9262) via an unspecified route of administration on 15Feb2021 at 08:45 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and high triglycerides. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included montelukast sodium ("SINGULAIR, MYLAN") from an unspecified date for an unspecified indication. The patient previously received dose 1 of BNT162B2 (lot number 9266) on 25Jan2021 at 08:45 for COVID-19 immunization and experienced pain at injection site/left arm, pain when raising arm. The patient previously received cephalosporins on an unknown date for an unknown indication and experienced allergy. Twenty-four hours after the second dose of BNT162B2 on 16Feb2021 at 09:00, the patient experienced lymph node pain and pain under armpit of arm where vaccine was given. The events were reported as non-serious. The patient was not hospitalized due to the events. The patient did not receive any treatment for the events. The outcome of lymph node pain and pain under armpit of arm where vaccine was given was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Lymph node pain
Clinical narrative: lymph node pain; pain under armpit of arm where vaccine was given; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number 9262) via an unspecified route of administration on 15Feb2021 at 08:45 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma and high triglycerides. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included montelukast sodium ("SINGULAIR, MYLAN") from an unspecified date for an unspecified indication. The patient previously received dose 1 of BNT162B2 (lot number 9266) on 25Jan2021 at 08:45 for COVID-19 immunization and experienced pain at injection site/left arm, pain when raising arm. The patient previously received cephalosporins on an unknown date for an unknown indication and experienced allergy. Twenty-four hours after the second dose of BNT162B2 on 16Feb2021 at 09:00, the patient experienced lymph node pain and pain under armpit of arm where vaccine was given. The events were reported as non-serious. The patient was not hospitalized due to the events. The patient did not receive any treatment for the events. The outcome of lymph node pain and pain under armpit of arm where vaccine was given was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Injection site pain & systemic arthritic; Injection site pain & systemic arthritic pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN9581) via an unspecified route of administration, administered on the right arm on 18Feb2021 11:30 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 on 28Jan2021 for COVID-19 immunisation (first dose on the right arm, lot number: EL8982); NSAIDs and sporins experienced allergies. On 18Feb2021 17:45 the patient experienced injection site pain & systemic arthritic pain. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.