chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes zoster, Impaired work ability, Pain, Pyrexia
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201, Expiration date: Not reported)  (at the age of 45-year-old) via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:00 as DOSE 2, SINGLE and first dose received on 02Feb2021 at 10:00 AM (Lot number: EZ9264) (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included estrogens conjugated (PREMARIN); erenumab aooe (AIMOVIG). The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 12:00 the patient experienced shingles (herpes zoster). AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles. Patient received treatment of IV medications in ER, multiple medications. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201, Expiration date: Not reported)  (at the age of 45-year-old) via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:00 as DOSE 2, SINGLE and first dose received on 02Feb2021 at 10:00 AM (Lot number: EZ9264) (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included estrogens conjugated (PREMARIN); erenumab aooe (AIMOVIG). The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 12:00 the patient experienced shingles (herpes zoster). AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles. Patient received treatment of IV medications in ER, multiple medications. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer. A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201, Expiration date: Not reported)  (at the age of 45-year-old) via an unspecified route of administration, administered in Arm Right on 25Feb2021 15:00 as DOSE 2, SINGLE and first dose received on 02Feb2021 at 10:00 AM (Lot number: EZ9264) (at the age of 45-year-old) for covid-19 immunisation. Concomitant medications included estrogens conjugated (PREMARIN); erenumab aooe (AIMOVIG). The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 12:00 the patient experienced shingles (herpes zoster). AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles. Patient received treatment of IV medications in ER, multiple medications. The outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Diplopia, Fatigue, Nausea, Pain
Clinical narrative: fever; Vomiting; double vision; body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021 at 10:45 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Apr2021 at 09:00, the patient experienced fever, vomiting, double vision, body aches. The patient underwent lab tests and procedures which included body temperature: fever on 24Apr2021 at 09:00. No treatment was received for the events. The outcome of the events was reported as resolving.  No Follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Trigeminal neuralgia, Vertigo, Vomiting
Clinical narrative: fever; Vomiting; double vision; body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021 at 10:45 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Apr2021 at 09:00, the patient experienced fever, vomiting, double vision, body aches. The patient underwent lab tests and procedures which included body temperature: fever on 24Apr2021 at 09:00. No treatment was received for the events. The outcome of the events was reported as resolving.  No Follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diplopia, Pain, Pyrexia, Vomiting
Clinical narrative: fever; Vomiting; double vision; body aches; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 55-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 23Apr2021 at 10:45 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing. No known allergies were reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Apr2021 at 09:00, the patient experienced fever, vomiting, double vision, body aches. The patient underwent lab tests and procedures which included body temperature: fever on 24Apr2021 at 09:00. No treatment was received for the events. The outcome of the events was reported as resolving.  No Follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Headache
Clinical narrative: double vision; continuous headaches.; This is a spontaneous report from a contactable consumer (patient himself). A 55-years-old male patient received second dose of bnt162b2 (Solution injection, Batch/Lot Number: EP7534), via an unspecified route of administration on 01Apr2021 (at the age of 55-years-old) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection, Batch/Lot Number: EN6203), via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, patient experienced since he got the Covid Vaccine; especially the second dose, he had been having continuous headaches and that last week he started having double vision, he still has this problem going on. He Stated that he went to the eye doctor and got tested but he does not know what else to do. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for herself). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient took the 1st vaccine of Pfizer and had a weird reaction. Patient's provider encouraged her to reach out to the company to see if she needs to take the 2nd shot. When she took the 1st shot, patient reported that she had tingling in area where the shot entered, her left arm on unspecified date. Patient also experienced numb sensation only in the left part of her body, from her face down and half her face was puffy on unspecified date. Patient had a fuzzy/tingle feeling in her mouth and tasted metal/tasted metal in the mouth. Patient reported that she took Benadryl and it helped. She asked that is it safe to take the 2nd shot. The clinical outcome of all events was unknown. Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia, Injection site paraesthesia, Paraesthesia oral, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient reported for herself). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient took the 1st vaccine of Pfizer and had a weird reaction. Patient's provider encouraged her to reach out to the company to see if she needs to take the 2nd shot. When she took the 1st shot, patient reported that she had tingling in area where the shot entered, her left arm on unspecified date. Patient also experienced numb sensation only in the left part of her body, from her face down and half her face was puffy on unspecified date. Patient had a fuzzy/tingle feeling in her mouth and tasted metal/tasted metal in the mouth. Patient reported that she took Benadryl and it helped. She asked that is it safe to take the 2nd shot. The clinical outcome of all events was unknown. Information about lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Encephalopathy
Clinical narrative: Patient's memory loss began 3/13/21 approximately one week after second Pfizer covid vaccine. Blacked out/lost time from this point until mid-June 2021 at which point I slowly began to recover short-term memory, but still not back to baseline as of today's date. Started prednisone for encephalitis 5/18/21 and took until 8/9/21 (including taper).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging normal
Clinical narrative: Patient's memory loss began 3/13/21 approximately one week after second Pfizer covid vaccine. Blacked out/lost time from this point until mid-June 2021 at which point I slowly began to recover short-term memory, but still not back to baseline as of today's date. Started prednisone for encephalitis 5/18/21 and took until 8/9/21 (including taper).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Encephalitis autoimmune, Inflammation, SARS-CoV-2 test
Clinical narrative: Patient's memory loss began 3/13/21 approximately one week after second Pfizer covid vaccine. Blacked out/lost time from this point until mid-June 2021 at which point I slowly began to recover short-term memory, but still not back to baseline as of today's date. Started prednisone for encephalitis 5/18/21 and took until 8/9/21 (including taper).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Anti-thyroid antibody, Blood test, Electroencephalogram, Loss of consciousness
Clinical narrative: Patient's memory loss began 3/13/21 approximately one week after second Pfizer covid vaccine. Blacked out/lost time from this point until mid-June 2021 at which point I slowly began to recover short-term memory, but still not back to baseline as of today's date. Started prednisone for encephalitis 5/18/21 and took until 8/9/21 (including taper).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Positron emission tomogram, Ultrasound pelvis, White blood cell count
Clinical narrative: Patient's memory loss began 3/13/21 approximately one week after second Pfizer covid vaccine. Blacked out/lost time from this point until mid-June 2021 at which point I slowly began to recover short-term memory, but still not back to baseline as of today's date. Started prednisone for encephalitis 5/18/21 and took until 8/9/21 (including taper).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear discomfort, Tinnitus
Clinical narrative: PAIN IN UPPER BACK; RINGING IN THE EARS; NUMBNESS DOWN LEFT ARM INTO  HAND; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced pain in upper back, ringing in the ears, and numbness down left arm into hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in upper back, and numbness down left arm into hand, and the outcome of ringing in the ears was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Hypoaesthesia, Tinnitus
Clinical narrative: PAIN IN UPPER BACK; RINGING IN THE EARS; NUMBNESS DOWN LEFT ARM INTO  HAND; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced pain in upper back, ringing in the ears, and numbness down left arm into hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in upper back, and numbness down left arm into hand, and the outcome of ringing in the ears was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Hypotension, Laboratory test, Laboratory test normal, Paraesthesia
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dizziness, Dyspnoea, Hypersensitivity
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, SARS-CoV-2 test, Tachycardia, Urticaria
Clinical narrative: anaphylaxis; allergic reactions; hypotension; hives; shortness of breath; chest pain; tachycardia; lightheadedness; This is a spontaneous report from a contactable nurse (patient) from the Pfizer-sponsored program, Pfizer.com - General Company Information. A 39-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ew0217), via an unspecified route of administration, administered in right arm on 12Jun2021 at 12:00 PM (age at vaccination was 39 years) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included endometriosis GERD and the patient previously used Advair and experienced allergic to Advair. Concomitant medication includes esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. On 12Jun2021 at 12:00 PM, the patient had an immediate reaction to the first vaccine with anaphylaxis, hypotension, tachycardia, hives, chest pain, shortness of breath and light headedness. Since this reaction the patient was in the emergency room (ER) over 10 times for allergic reactions, had 4 ambulance rides, and a nine day admission for unexplained hypertension and tachycardia now placed on beta blockers. The patient was looking for someone from company to help me find a healthcare professional to deal with symptoms and allow to get back to normal daily life. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, prolongation of existing hospitalization (vaccine received during existing hospitalization). Therapeutic measures were taken as a result of reported events with steroids beta blockers fluids. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient tested for COVID-19. On 15Aug2021, the patient underwent lab tests which included nasal swab: negative. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of anaphylactic reaction,hypotension,urticaria,dyspnoea,dizziness,tachycardia cannot be excluded.But also consider patient had relevant medical history of breast cancer and breast surgery present.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: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram PR interval
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram QRS complex shortened, Electrocardiogram QT interval, Electrocardiogram ST segment elevation, Electrocardiogram T wave abnormal, Electrocardiogram abnormal
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram repolarisation abnormality, Limb discomfort, Myocardial infarction, Myocarditis, Pain
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sinus bradycardia, Troponin increased, Vaccination complication
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adenovirus test, Blood alcohol normal, Chest X-ray normal, Chest discomfort, Cytomegalovirus test negative
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count normal, Echocardiogram normal, Electrocardiogram ST segment elevation, Enterovirus test negative, Full blood count normal
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: HIV test negative, Laboratory test, Limb discomfort, Metabolic function test normal, Myocarditis
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Troponin increased
Clinical narrative: Five days after receiving the Pfizer COVID-19 vaccine, he woke up and began having chest tightness, going down his left arm.  He also had some bodyaches.  He is healthy and has negative past medical history.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: dizziness
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Musculoskeletal stiffness, Nausea
Clinical narrative: Nausea, excess saliva, dizziness,chills,heavy fatigue, high sense of smell,sore body, painful headache, appetite decrease.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Pyrexia, Salivary hypersecretion
Clinical narrative: Nausea, excess saliva, dizziness,chills,heavy fatigue, high sense of smell,sore body, painful headache, appetite decrease.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Nausea, excess saliva, dizziness,chills,heavy fatigue, high sense of smell,sore body, painful headache, appetite decrease.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Nausea, Pain, Parasite blood test, Parosmia
Clinical narrative: Nausea, excess saliva, dizziness,chills,heavy fatigue, high sense of smell,sore body, painful headache, appetite decrease.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: SARS-CoV-2 test, Salivary hypersecretion
Clinical narrative: Nausea, excess saliva, dizziness,chills,heavy fatigue, high sense of smell,sore body, painful headache, appetite decrease.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Rash beginning at injection site; slightly swollen; red; itchy; slightly sore; Left side of tongue and under the left side of tongue feel like they've been injected with novocaine; left side of neck feels slightly numb; going down about 6 inches on the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: F87484), via an unspecified route of administration, administered in Arm Left on 29Jul2021 17:00 (at the age of 59 years old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood Pressure from an unknown date and unknown if ongoing, Acid Reflux (gastrooesophageal reflux) disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, Thyroid Nodules (thyroid mass) from an unknown date and unknown if ongoing. Concomitant medication(s) included VIT C (Ascorbic Acid); VIT. E (Tocopherol); Vitamin D3, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took percocet [oxycodone hydrochloride;paracetamol], cefdinir, Enbrel and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021 12:00 administered in left arm as single dose for. The patient was not pregnant at the time of vaccination. It was reported that covid prior to vaccination was No. It was reported that covid tested post vaccination was No. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced rash beginning at injection site, slightly swollen, red, itchy, slightly sore, left side of tongue and under the left side of tongue feel like they've been injected with novocaine, left side of neck feels slightly numb, going down about 6 inches on the arm on 02Aug2021 08:00. No trouble swallowing but feels funny. Therapeutic measures were taken as no as a result of all events. The outcome of events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Swollen tongue
Clinical narrative: Rash beginning at injection site; slightly swollen; red; itchy; slightly sore; Left side of tongue and under the left side of tongue feel like they've been injected with novocaine; left side of neck feels slightly numb; going down about 6 inches on the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: F87484), via an unspecified route of administration, administered in Arm Left on 29Jul2021 17:00 (at the age of 59 years old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood Pressure from an unknown date and unknown if ongoing, Acid Reflux (gastrooesophageal reflux) disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, Thyroid Nodules (thyroid mass) from an unknown date and unknown if ongoing. Concomitant medication(s) included VIT C (Ascorbic Acid); VIT. E (Tocopherol); Vitamin D3, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took percocet [oxycodone hydrochloride;paracetamol], cefdinir, Enbrel and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021 12:00 administered in left arm as single dose for. The patient was not pregnant at the time of vaccination. It was reported that covid prior to vaccination was No. It was reported that covid tested post vaccination was No. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced rash beginning at injection site, slightly swollen, red, itchy, slightly sore, left side of tongue and under the left side of tongue feel like they've been injected with novocaine, left side of neck feels slightly numb, going down about 6 inches on the arm on 02Aug2021 08:00. No trouble swallowing but feels funny. Therapeutic measures were taken as no as a result of all events. The outcome of events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Paraesthesia oral, Peripheral swelling
Clinical narrative: Rash beginning at injection site; slightly swollen; red; itchy; slightly sore; Left side of tongue and under the left side of tongue feel like they've been injected with novocaine; left side of neck feels slightly numb; going down about 6 inches on the arm; This is a spontaneous report from a contactable consumer or other non hcp. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: F87484), via an unspecified route of administration, administered in Arm Left on 29Jul2021 17:00 (at the age of 59 years old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included High Blood Pressure from an unknown date and unknown if ongoing, Acid Reflux (gastrooesophageal reflux) disease from an unknown date and unknown if ongoing, glaucoma from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing, Thyroid Nodules (thyroid mass) from an unknown date and unknown if ongoing. Concomitant medication(s) included VIT C (Ascorbic Acid); VIT. E (Tocopherol); Vitamin D3, all taken for an unspecified indication, start and stop date were not reported.  The patient previously took percocet [oxycodone hydrochloride;paracetamol], cefdinir, Enbrel and had allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), via an unspecified route of administration on 08Jul2021 12:00 administered in left arm as single dose for. The patient was not pregnant at the time of vaccination. It was reported that covid prior to vaccination was No. It was reported that covid tested post vaccination was No. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient experienced rash beginning at injection site, slightly swollen, red, itchy, slightly sore, left side of tongue and under the left side of tongue feel like they've been injected with novocaine, left side of neck feels slightly numb, going down about 6 inches on the arm on 02Aug2021 08:00. No trouble swallowing but feels funny. Therapeutic measures were taken as no as a result of all events. The outcome of events was unknown.