chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: I now have great pain and loss of range of motion in my left shoulder. Both the first shot and the second were given at the tip of my shoulder. I had to take my shirt off to give the persons giving the shots the access they wanted. When I asked why so high up the arm both ladies told me this was "per CDC guidelines" like it was a rehearsed response.  My doctor and everyone I talked to said the shots should have been in the muscle lower down the arm from the shoulder. Pharmacy has bad information as to how to correctly give the shot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Back pain, Balance disorder, Burning sensation
Clinical narrative: feeling so terrible; Brain Fog; weak legs; Dyspnea while walking; I am nervous; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Aug2021 (Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Medical history included hypogammaglobulinaemia, kind of immune deficiency disorder. Concomitant medications included immunoglobulin human normal (CUVITRU) taken for hypogammaglobulinaemia, start and stop date were not reported. The patient had a COVID test done on 29Jul2021 before she received the vaccine with unknown result. The patient did not receive any prior vaccination within 4 weeks of COVID-19 vaccine. The patient wanted to know if receiving the COVID-19 vaccine in her condition was safe because of what she had taken for her therapy, then asked why she was feeling so terrible. On the morning of 28Aug2021, the patient experienced brain fog, weak legs and dyspnea while walking. She wanted anything like a confirmation that she had reported because she was also nervous. The patient took ibuprofen (200 mg, two little 100 mg) as the treatment for the events and just had been drinking water to stay hydrated. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Feeling abnormal, Headache, Muscular weakness
Clinical narrative: feeling so terrible; Brain Fog; weak legs; Dyspnea while walking; I am nervous; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Aug2021 (Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Medical history included hypogammaglobulinaemia, kind of immune deficiency disorder. Concomitant medications included immunoglobulin human normal (CUVITRU) taken for hypogammaglobulinaemia, start and stop date were not reported. The patient had a COVID test done on 29Jul2021 before she received the vaccine with unknown result. The patient did not receive any prior vaccination within 4 weeks of COVID-19 vaccine. The patient wanted to know if receiving the COVID-19 vaccine in her condition was safe because of what she had taken for her therapy, then asked why she was feeling so terrible. On the morning of 28Aug2021, the patient experienced brain fog, weak legs and dyspnea while walking. She wanted anything like a confirmation that she had reported because she was also nervous. The patient took ibuprofen (200 mg, two little 100 mg) as the treatment for the events and just had been drinking water to stay hydrated. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Paraesthesia, Pruritus, Rash
Clinical narrative: feeling so terrible; Brain Fog; weak legs; Dyspnea while walking; I am nervous; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Aug2021 (Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Medical history included hypogammaglobulinaemia, kind of immune deficiency disorder. Concomitant medications included immunoglobulin human normal (CUVITRU) taken for hypogammaglobulinaemia, start and stop date were not reported. The patient had a COVID test done on 29Jul2021 before she received the vaccine with unknown result. The patient did not receive any prior vaccination within 4 weeks of COVID-19 vaccine. The patient wanted to know if receiving the COVID-19 vaccine in her condition was safe because of what she had taken for her therapy, then asked why she was feeling so terrible. On the morning of 28Aug2021, the patient experienced brain fog, weak legs and dyspnea while walking. She wanted anything like a confirmation that she had reported because she was also nervous. The patient took ibuprofen (200 mg, two little 100 mg) as the treatment for the events and just had been drinking water to stay hydrated. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea exertional, Feeling abnormal, Malaise, Muscular weakness
Clinical narrative: feeling so terrible; Brain Fog; weak legs; Dyspnea while walking; I am nervous; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Aug2021 (Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Medical history included hypogammaglobulinaemia, kind of immune deficiency disorder. Concomitant medications included immunoglobulin human normal (CUVITRU) taken for hypogammaglobulinaemia, start and stop date were not reported. The patient had a COVID test done on 29Jul2021 before she received the vaccine with unknown result. The patient did not receive any prior vaccination within 4 weeks of COVID-19 vaccine. The patient wanted to know if receiving the COVID-19 vaccine in her condition was safe because of what she had taken for her therapy, then asked why she was feeling so terrible. On the morning of 28Aug2021, the patient experienced brain fog, weak legs and dyspnea while walking. She wanted anything like a confirmation that she had reported because she was also nervous. The patient took ibuprofen (200 mg, two little 100 mg) as the treatment for the events and just had been drinking water to stay hydrated. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: feeling so terrible; Brain Fog; weak legs; Dyspnea while walking; I am nervous; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Aug2021 (Lot Number: EW0217) (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Medical history included hypogammaglobulinaemia, kind of immune deficiency disorder. Concomitant medications included immunoglobulin human normal (CUVITRU) taken for hypogammaglobulinaemia, start and stop date were not reported. The patient had a COVID test done on 29Jul2021 before she received the vaccine with unknown result. The patient did not receive any prior vaccination within 4 weeks of COVID-19 vaccine. The patient wanted to know if receiving the COVID-19 vaccine in her condition was safe because of what she had taken for her therapy, then asked why she was feeling so terrible. On the morning of 28Aug2021, the patient experienced brain fog, weak legs and dyspnea while walking. She wanted anything like a confirmation that she had reported because she was also nervous. The patient took ibuprofen (200 mg, two little 100 mg) as the treatment for the events and just had been drinking water to stay hydrated. The outcome of the events was unknown.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Dizziness within 30 minutes of injection; headache and severe muscle pain within 1 hour of injection; headache and severe muscle pain within 1 hour of injection; Low fever within 2 hours of injection; Fatigue and exhaustion within 6 hours of injection; Blurred vision within 12 hours of injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC 3183) via an unspecified route of administration in the right arm on 01Sep2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID- 19 and allergic to peanuts and corn. Concomitant medications taken within two weeks of vaccination included salbutamol (ALBUTEROL), budesonide (MANUFACTURER UNKNOWN) and formoterol (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021, the patient experienced dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection was resolving at the time of this report.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Dizziness within 30 minutes of injection; headache and severe muscle pain within 1 hour of injection; headache and severe muscle pain within 1 hour of injection; Low fever within 2 hours of injection; Fatigue and exhaustion within 6 hours of injection; Blurred vision within 12 hours of injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC 3183) via an unspecified route of administration in the right arm on 01Sep2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID- 19 and allergic to peanuts and corn. Concomitant medications taken within two weeks of vaccination included salbutamol (ALBUTEROL), budesonide (MANUFACTURER UNKNOWN) and formoterol (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021, the patient experienced dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection was resolving at the time of this report.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Dizziness within 30 minutes of injection; headache and severe muscle pain within 1 hour of injection; headache and severe muscle pain within 1 hour of injection; Low fever within 2 hours of injection; Fatigue and exhaustion within 6 hours of injection; Blurred vision within 12 hours of injection; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC 3183) via an unspecified route of administration in the right arm on 01Sep2021 at 11:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID- 19 and allergic to peanuts and corn. Concomitant medications taken within two weeks of vaccination included salbutamol (ALBUTEROL), budesonide (MANUFACTURER UNKNOWN) and formoterol (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Sep2021, the patient experienced dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness within 30 minutes of injection, headache and severe muscle pain within one hour of injection, low fever within two hours of injection, fatigue and exhaustion within six hours of injection, blurred vision within 12 hours of injection was resolving at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Urticaria within 24 hrs; confusion; weakness; fever; febrile; nausea; vomiting; diarrhea; gait instability; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) 40mg unspecified days, hydroxyzine (ATARAX) 25mg as necessary and ondansetron (ZOFRAN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021 at 22:00, the patient experienced urticaria within 24hours, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with Steroids, topical steroid and antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urticaria, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability were not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Gait disturbance, Nausea
Clinical narrative: Urticaria within 24 hrs; confusion; weakness; fever; febrile; nausea; vomiting; diarrhea; gait instability; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) 40mg unspecified days, hydroxyzine (ATARAX) 25mg as necessary and ondansetron (ZOFRAN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021 at 22:00, the patient experienced urticaria within 24hours, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with Steroids, topical steroid and antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urticaria, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability were not resolved at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: Urticaria within 24 hrs; confusion; weakness; fever; febrile; nausea; vomiting; diarrhea; gait instability; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 28Aug2021 at 17:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) 40mg unspecified days, hydroxyzine (ATARAX) 25mg as necessary and ondansetron (ZOFRAN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021 at 22:00, the patient experienced urticaria within 24hours, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with Steroids, topical steroid and antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events urticaria, confusion, weakness, fever, febrile, nausea, vomiting, diarrhea and gait instability were not resolved at the time of this report.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; VACCINE WAS REFRIGERATED THEN REFROZEN AT MINIMUM TEMPERATURE -11.6F AND MAXIMUM AT 3.7F; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f. On 30-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905531.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; VACCINE WAS REFRIGERATED THEN REFROZEN AT MINIMUM TEMPERATURE -11.6F AND MAXIMUM AT 3.7F; This spontaneous report received from a health care professional concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f. On 30-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and vaccine was refrigerated then refrozen at minimum temperature -11.6f and maximum at 3.7f was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905531.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL AFTER 6 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced incorrect product storage. On 02-SEP-2021, the patient experienced administration of vaccine from punctured vial after 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of vaccine from punctured vial after 6 hours and incorrect product storage was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL AFTER 6 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced incorrect product storage. On 02-SEP-2021, the patient experienced administration of vaccine from punctured vial after 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of vaccine from punctured vial after 6 hours and incorrect product storage was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 by RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1555.  Patient notified of error on 9/3/2021 at 1600.  Reports feeling  good and would like to be revaccinated next week per recommendation of our medical director.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 by RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1555.  Patient notified of error on 9/3/2021 at 1600.  Reports feeling  good and would like to be revaccinated next week per recommendation of our medical director.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Lip erythema, Lip swelling, Skin warm
Clinical narrative: Swollen upper and lower lip; Swollen joints; Red; Hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration on 20May2021 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included large scrape on shin which occurred 3 weeks prior to adverse reaction and required 2 weeks of bandaging and neosporin. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included neomycin sulfate/polymyxin b sulfate/bacitracin (NEOSPORIN) from an unknown date for an unknown indication and unknown if ongoing. On 27May2021, the patient experienced swollen upper and lower lip, swollen joints, red and hot to touch. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with unspecified medications and the patient was referred to allergist. The clinical outcome of the events swollen upper and lower lip, swollen joints, red and hot to the touch were resolved on an unknown date in 2021.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Joint swelling, Lip swelling, Skin warm
Clinical narrative: Swollen upper and lower lip; Swollen joints; Red; Hot to the touch; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration on 20May2021 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included large scrape on shin which occurred 3 weeks prior to adverse reaction and required 2 weeks of bandaging and neosporin. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included neomycin sulfate/polymyxin b sulfate/bacitracin (NEOSPORIN) from an unknown date for an unknown indication and unknown if ongoing. On 27May2021, the patient experienced swollen upper and lower lip, swollen joints, red and hot to touch. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with unspecified medications and the patient was referred to allergist. The clinical outcome of the events swollen upper and lower lip, swollen joints, red and hot to the touch were resolved on an unknown date in 2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Autoimmune disorder, C-reactive protein normal, Extremity contracture, Gait inability
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint contracture, Joint swelling, Mobility decreased, Red blood cell sedimentation rate increased, Tendon pain
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Torticollis, Trigger finger
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Condition aggravated, Gait inability, Impaired work ability, Inflammation
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle contracture, SARS-CoV-2 test negative, Tendon pain
Clinical narrative: severe flare up of auto immune disease. Joint and tendon pain in wrists (causing swelling and contractures), all fingers and thumbs causing trigger finger in all digits, bilateral elbows, bilateral shoulders, bilateral ankles (swelling & contracture), bilateral knee pain & swelling. Unable to walk, unable to use hands or fingers, unable to turn head due to sever torticollis. Nodules on bilateral wrists, collarbone, bilateral ankles, large toes..all happened AFTER vaccine administration. 8/26/2021 - E.R. - left after waiting 5 hours, unable to walk. 8/28/2021 - E.R. - treated with Toradol 30 mg IV; Dilaudid 0.5 mg IV, rx given for toradol 10 mg to take 1 tabs 4x's/day X 5 days. No relief..lstopped Toradol. 8/30/2021 - call to Dr. and started on Medrol Dosepack. 8/31-/2020 - video visit with Dr - no relief from Medrol Dosepack. 9/03/2021 startred Prednisone 20 mg daily X 4 days and taper down by 5 mg every 4 days. 9/07/2021 - prednisone changed to 20 mg  dailyX 10 days days and taper down as needed. Unable to work (work as an RN due to sever pain an dcontractures). Dr working on authorization for Remicade infusion to start again due to severe flare up of symptoms.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized for covid  pna
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: hospitalized for covid  pna
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 by RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1533.  Patient notified of error on 9/3/2021 at 1557.  Reports feeling achy, but otherwise good and declined getting vaccinated again.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Pain
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 by RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1533.  Patient notified of error on 9/3/2021 at 1557.  Reports feeling achy, but otherwise good and declined getting vaccinated again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1545.  Patient notified of error on 9/3/2021 at 1552.  Reports feeling tired, but otherwise good and declined getting vaccinated again.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product storage error
Clinical narrative: Patient was vaccinated several hours after vaccine was no longer good.  Vial punctured at 0900 RN and left out at room temperature.  Vaccine was not to be used after 1100 AM, but vaccinated patient at 1545.  Patient notified of error on 9/3/2021 at 1552.  Reports feeling tired, but otherwise good and declined getting vaccinated again.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Had a large reaction; Arms are real sore; her lymph node were swollen under her arms; she felt little tired and really fatigue; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction and all 'three' arms are real sore on an unspecified date. The patient's (daughter) lymph node were swollen under her arms and she felt little tired and really fatigue and had a bad headache on an unknown date. The reporter stated that she spoken to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She stated expiration date as 30Aug202 (Further not clarified). As reporter was having trouble hearing, hence further probing could not be done. Limited information was available over the call. The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a large reaction; Arms are real sore; her lymph node were swollen under her arms; she felt little tired and really fatigue; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction and all 'three' arms are real sore on an unspecified date. The patient's (daughter) lymph node were swollen under her arms and she felt little tired and really fatigue and had a bad headache on an unknown date. The reporter stated that she spoken to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She stated expiration date as 30Aug202 (Further not clarified). As reporter was having trouble hearing, hence further probing could not be done. Limited information was available over the call. The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain in extremity, Vaccination complication
Clinical narrative: Had a large reaction; Arms are real sore; her lymph node were swollen under her arms; she felt little tired and really fatigue; headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction and all 'three' arms are real sore on an unspecified date. The patient's (daughter) lymph node were swollen under her arms and she felt little tired and really fatigue and had a bad headache on an unknown date. The reporter stated that she spoken to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She stated expiration date as 30Aug202 (Further not clarified). As reporter was having trouble hearing, hence further probing could not be done. Limited information was available over the call. The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 24Aug; I have gotten my third shot of Pfizer on 19Aug; I have gotten my third shot of Pfizer on 19Aug; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), dose 3 via an unspecified route of administration on 19Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 on an unspecified date for COVID-19 immunization. Patient reported that I had got my third shot of Pfizer on 19Aug2021 and tested positive for covid on 24Aug2021 and now past ten days with no further symptoms from covid. I also got the anticolonial antibody treatment on 25Aug2021. Patient wanted to know do I need another booster now or in 90 days. The patient underwent lab tests and procedures which included Covid-19: positive on 24Aug2021. The events were assessed as non-serious. Therapeutic measures were taken as a result of tested positive for covid on 24aug. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid on 24Aug; I have gotten my third shot of Pfizer on 19Aug; I have gotten my third shot of Pfizer on 19Aug; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), dose 3 via an unspecified route of administration on 19Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 on an unspecified date for COVID-19 immunization. Patient reported that I had got my third shot of Pfizer on 19Aug2021 and tested positive for covid on 24Aug2021 and now past ten days with no further symptoms from covid. I also got the anticolonial antibody treatment on 25Aug2021. Patient wanted to know do I need another booster now or in 90 days. The patient underwent lab tests and procedures which included Covid-19: positive on 24Aug2021. The events were assessed as non-serious. Therapeutic measures were taken as a result of tested positive for covid on 24aug. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Extra dose administered, Off label use, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 24Aug; I have gotten my third shot of Pfizer on 19Aug; I have gotten my third shot of Pfizer on 19Aug; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), dose 3 via an unspecified route of administration on 19Aug2021 as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 on an unspecified date for COVID-19 immunization. Patient reported that I had got my third shot of Pfizer on 19Aug2021 and tested positive for covid on 24Aug2021 and now past ten days with no further symptoms from covid. I also got the anticolonial antibody treatment on 25Aug2021. Patient wanted to know do I need another booster now or in 90 days. The patient underwent lab tests and procedures which included Covid-19: positive on 24Aug2021. The events were assessed as non-serious. Therapeutic measures were taken as a result of tested positive for covid on 24aug. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.