chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Malaise, Pain in extremity, Pyrexia, Suspected COVID-19
Clinical narrative: Got sick; Fever; Arm was so sore, couldn't even pick up arm; Arm was so sore, couldn't even pick up arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2020 (Lot number: EK5730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered", LIMB DISCOMFORT (non-serious) with onset 24Dec2020, outcome "unknown" and all described as "Arm was so sore, couldn't even pick up arm"; ILLNESS (non-serious), outcome "unknown", described as "Got sick"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: There were no any vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no requirement to visit emergency Room or physician Office. There were no prior vaccinations within four weeks to the first administration date of the suspect vaccine. No, only other vaccinations caller has ever gotten were when was a young kid for measles, mumps and rubella. There were no any relevant tests done.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Got sick; Fever; Arm was so sore, couldn't even pick up arm; Arm was so sore, couldn't even pick up arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2020 (Lot number: EK5730) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Dec2020, outcome "recovered", LIMB DISCOMFORT (non-serious) with onset 24Dec2020, outcome "unknown" and all described as "Arm was so sore, couldn't even pick up arm"; ILLNESS (non-serious), outcome "unknown", described as "Got sick"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: There were no any vaccines administered on same date with the Pfizer vaccine considered as suspect. There were no requirement to visit emergency Room or physician Office. There were no prior vaccinations within four weeks to the first administration date of the suspect vaccine. No, only other vaccinations caller has ever gotten were when was a young kid for measles, mumps and rubella. There were no any relevant tests done.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Haemoglobin, Investigation, Migraine
Clinical narrative: Migraine; Nauseous; Dizzy/ light headed; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 08:30 (Lot number: 30130BA) at the age of 45 years as dose 1, 0.3 ml single and administered in arm left, administration date 10Jan2022 08:30 (Lot number: FL3198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (ongoing), notes: Hashimoto's disease, Diagnosed about 2018; "Fibromyalgia" (ongoing), notes: Fibromyalgia, Diagnosed about 2018; "Chronic urticaria", start date: 2016 (ongoing), notes: Chronic Urticaria; "Angioedema", start date: 2016 (ongoing), notes: Angioedema; "Alopecia", start date: 2018 (ongoing), notes: Alopecia; "Eczema", start date: 2016 (ongoing), notes: Eczema; "Covid", start date: Oct2020 (unspecified if ongoing), notes: had the Covid virus in Oct2020. Family history included: "Asthma", start date: 2016 (ongoing), notes: Asthma, Family Medical History Relevant to AE(s): Grandmother has Asthma; "COPD" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has COPD; "Heart disease" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has Heart disease. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, administration date: 10Dec2021, when the patient was 45 years old, for Immunization, reaction(s): "angioedema", "swelling", "hives", "allergy to eggs"; Flu shot (She hadn't had one since 2014), administration date: 2014, for Immunization, reaction(s): "She hadn't had one". The following information was reported: MIGRAINE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Migraine"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Dizzy/ light headed"; FATIGUE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: She has several autoimmune diseases and is immune compromised. She addressed her migraines and prescribed Atenolol. After each injection the symptoms began within 15 to 20 minutes. After each injection the symptoms began within 15 to 20 minutes. After the first dose, she made the mistake of not eating prior to receiving the vaccine. She had to stay there for an hour after the injection because she was so lightheaded and dizzy that the room was spinning; they had her lay down. The second time they didn't have staff so they had her sit in the hallway in a chair, 15 to 20 minutes after each vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Thyroid function test
Clinical narrative: Migraine; Nauseous; Dizzy/ light headed; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 08:30 (Lot number: 30130BA) at the age of 45 years as dose 1, 0.3 ml single and administered in arm left, administration date 10Jan2022 08:30 (Lot number: FL3198) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (ongoing), notes: Hashimoto's disease, Diagnosed about 2018; "Fibromyalgia" (ongoing), notes: Fibromyalgia, Diagnosed about 2018; "Chronic urticaria", start date: 2016 (ongoing), notes: Chronic Urticaria; "Angioedema", start date: 2016 (ongoing), notes: Angioedema; "Alopecia", start date: 2018 (ongoing), notes: Alopecia; "Eczema", start date: 2016 (ongoing), notes: Eczema; "Covid", start date: Oct2020 (unspecified if ongoing), notes: had the Covid virus in Oct2020. Family history included: "Asthma", start date: 2016 (ongoing), notes: Asthma, Family Medical History Relevant to AE(s): Grandmother has Asthma; "COPD" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has COPD; "Heart disease" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Grandmother has Heart disease. The patient's concomitant medications were not reported. Vaccination history included: Flu shot, administration date: 10Dec2021, when the patient was 45 years old, for Immunization, reaction(s): "angioedema", "swelling", "hives", "allergy to eggs"; Flu shot (She hadn't had one since 2014), administration date: 2014, for Immunization, reaction(s): "She hadn't had one". The following information was reported: MIGRAINE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Migraine"; NAUSEA (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 20Dec2021, outcome "not recovered", described as "Dizzy/ light headed"; FATIGUE (non-serious) with onset 20Dec2021, outcome "not recovered", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine.  Additional information: She has several autoimmune diseases and is immune compromised. She addressed her migraines and prescribed Atenolol. After each injection the symptoms began within 15 to 20 minutes. After each injection the symptoms began within 15 to 20 minutes. After the first dose, she made the mistake of not eating prior to receiving the vaccine. She had to stay there for an hour after the injection because she was so lightheaded and dizzy that the room was spinning; they had her lay down. The second time they didn't have staff so they had her sit in the hallway in a chair, 15 to 20 minutes after each vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Limb mass, Movement disorder, Neoplasm, Pain in extremity
Clinical narrative: first dose- can feel a lump in right arm; first dose- lump goes back up in her neck; first dose- can hardly move her neck; first dose- stated that she is not eating; first dose-right arm sore/has a lot of pain in her right arm; first dose- stated that she lost so much weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious), outcome "not recovered", described as "first dose- can feel a lump in right arm"; NEOPLASM (non-serious), outcome "not recovered", described as "first dose- lump goes back up in her neck"; PAIN IN EXTREMITY (non-serious) with onset 05Dec2021, outcome "not recovered", described as "first dose-right arm sore/has a lot of pain in her right arm"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "first dose- can hardly move her neck"; WEIGHT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "first dose- stated that she lost so much weight"; EATING DISORDER (non-serious), outcome "unknown", described as "first dose- stated that she is not eating". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: first dose- can feel a lump in right arm; first dose- lump goes back up in her neck; first dose- can hardly move her neck; first dose- stated that she is not eating; first dose-right arm sore/has a lot of pain in her right arm; first dose- stated that she lost so much weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Dec2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious), outcome "not recovered", described as "first dose- can feel a lump in right arm"; NEOPLASM (non-serious), outcome "not recovered", described as "first dose- lump goes back up in her neck"; PAIN IN EXTREMITY (non-serious) with onset 05Dec2021, outcome "not recovered", described as "first dose-right arm sore/has a lot of pain in her right arm"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "first dose- can hardly move her neck"; WEIGHT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "first dose- stated that she lost so much weight"; EATING DISORDER (non-serious), outcome "unknown", described as "first dose- stated that she is not eating". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_date= 18Nov2021, covid_test_result=Positive; covid_test_date= 18Nov2021, covid_test_result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 18:00 (Lot number: 3203080) at the age of 43 years as dose 3 (booster), single, administered in arm left, administration date 20Apr2021 12:00 (Lot number: EN0172) as dose 2, single and administered in arm left, administration date 30Mar2021 12:00 (Lot number: ER8734) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "covid_test_date= 18Nov2021, covid_test_result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive, notes: COVID test type post vaccination: Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; 3rd booster made me feel flu-like for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302), administration date: Feb2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2022, outcome "not recovered", described as "Tinnitus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "3rd booster made me feel flu-like for 24 hours". The events "tinnitus" and "3rd booster made me feel flu-like for 24 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, influenza like illness.  Additional information: Seriousness criteria's was assessed as non-serious by reporter. No other vaccine in four weeks. Tinnitus onset mid-February 2022, approximately 1 month after COVID. Unsure if Tinnitus is related to Covid itself or vaccine. No after 1st and 2nd shots. Started after patient's Covid diagnosis and patient's 3rd shot. 3rd booster made patient feel flulike for 24 hours. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear - no ear infection found or other symptoms/pain. Never had ear issues in my life before except occasional very brief bouts of tinnitus. But now it's almost constant  whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in patient's right ear. Extremely distracting and interferes with patient's job as a therapist, in which patient must focus and listen to patient's clients all day. AE resulted in was doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. COVID was tested post vaccination. Test type post vaccination was nasal swab, done on Jan2022 and COVID test result was positive.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tinnitus; 3rd booster made me feel flu-like for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302), administration date: Feb2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2022, outcome "not recovered", described as "Tinnitus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "3rd booster made me feel flu-like for 24 hours". The events "tinnitus" and "3rd booster made me feel flu-like for 24 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, influenza like illness.  Additional information: Seriousness criteria's was assessed as non-serious by reporter. No other vaccine in four weeks. Tinnitus onset mid-February 2022, approximately 1 month after COVID. Unsure if Tinnitus is related to Covid itself or vaccine. No after 1st and 2nd shots. Started after patient's Covid diagnosis and patient's 3rd shot. 3rd booster made patient feel flulike for 24 hours. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear - no ear infection found or other symptoms/pain. Never had ear issues in my life before except occasional very brief bouts of tinnitus. But now it's almost constant  whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in patient's right ear. Extremely distracting and interferes with patient's job as a therapist, in which patient must focus and listen to patient's clients all day. AE resulted in was doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. COVID was tested post vaccination. Test type post vaccination was nasal swab, done on Jan2022 and COVID test result was positive.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Tinnitus; 3rd booster made me feel flu-like for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: Mar2021, when the patient was 36 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302), administration date: Feb2021, when the patient was 36 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Feb2022, outcome "not recovered", described as "Tinnitus"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "3rd booster made me feel flu-like for 24 hours". The events "tinnitus" and "3rd booster made me feel flu-like for 24 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, influenza like illness.  Additional information: Seriousness criteria's was assessed as non-serious by reporter. No other vaccine in four weeks. Tinnitus onset mid-February 2022, approximately 1 month after COVID. Unsure if Tinnitus is related to Covid itself or vaccine. No after 1st and 2nd shots. Started after patient's Covid diagnosis and patient's 3rd shot. 3rd booster made patient feel flulike for 24 hours. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear - no ear infection found or other symptoms/pain. Never had ear issues in my life before except occasional very brief bouts of tinnitus. But now it's almost constant  whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in patient's right ear. Extremely distracting and interferes with patient's job as a therapist, in which patient must focus and listen to patient's clients all day. AE resulted in was doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. COVID was tested post vaccination. Test type post vaccination was nasal swab, done on Jan2022 and COVID test result was positive.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test, Tinnitus
Clinical narrative: COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; Low fever; Congestion; COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) as dose 3 (booster), single, administration date Mar2021 (Lot number: EL3247) as dose 2, single and administration date Feb2021 (Lot number: EL3302) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive"; PYREXIA (non-serious) with onset Feb2022, outcome "not recovered", described as "Low fever"; NASAL CONGESTION (non-serious) with onset Feb2022, outcome "not recovered", described as "Congestion". The events "low fever" and "congestion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (Feb2022) low fever; sars-cov-2 test: (Jan2022) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of pyrexia, nasal congestion.  Clinical Course: Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Antibiotics was received for adverse event in case it was due to sinus infection. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19. She started after her Covid diagnosis. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear-no ear infection found or other symptoms/pain. Never had ear issues in her life before except occasional very brief bouts of tinnitus. But now it's almost constant-whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in my right ear. Extremely distracting and interferes with my job as a therapist, in which she must focus and listen to her clients all day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; Low fever; Congestion; COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) as dose 3 (booster), single, administration date Mar2021 (Lot number: EL3247) as dose 2, single and administration date Feb2021 (Lot number: EL3302) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive"; PYREXIA (non-serious) with onset Feb2022, outcome "not recovered", described as "Low fever"; NASAL CONGESTION (non-serious) with onset Feb2022, outcome "not recovered", described as "Congestion". The events "low fever" and "congestion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (Feb2022) low fever; sars-cov-2 test: (Jan2022) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of pyrexia, nasal congestion.  Clinical Course: Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Antibiotics was received for adverse event in case it was due to sinus infection. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19. She started after her Covid diagnosis. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear-no ear infection found or other symptoms/pain. Never had ear issues in her life before except occasional very brief bouts of tinnitus. But now it's almost constant-whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in my right ear. Extremely distracting and interferes with my job as a therapist, in which she must focus and listen to her clients all day.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; Low fever; Congestion; COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Lot number: FL3198) as dose 3 (booster), single, administration date Mar2021 (Lot number: EL3247) as dose 2, single and administration date Feb2021 (Lot number: EL3302) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jan2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID diagnosis /COVID_test_date=Jan2022, COVID_test_result=Positive"; PYREXIA (non-serious) with onset Feb2022, outcome "not recovered", described as "Low fever"; NASAL CONGESTION (non-serious) with onset Feb2022, outcome "not recovered", described as "Congestion". The events "low fever" and "congestion" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (Feb2022) low fever; sars-cov-2 test: (Jan2022) positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of pyrexia, nasal congestion.  Clinical Course: Patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Antibiotics was received for adverse event in case it was due to sinus infection. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19. She started after her Covid diagnosis. Covid itself was extremely mild, just a low fever and some congestion. Mostly right ear-no ear infection found or other symptoms/pain. Never had ear issues in her life before except occasional very brief bouts of tinnitus. But now it's almost constant-whooshing sound sometimes, buzzing sometimes, and most awful, a sound like a low foghorn in my right ear. Extremely distracting and interferes with my job as a therapist, in which she must focus and listen to her clients all day.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4298360-00 (RA). A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2022 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single, intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Lot number: 1154543) at 150 mg (150 mg, (1 in 12 wk.)) for psoriasis. Relevant medical history included: "Covid" (unspecified if ongoing), notes: Other relevant history: 2nd time getting Covid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21Feb2022, outcome "recovering" and all described as "COVID-19". The action taken for Risankizumab was dosage not changed. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient had No known allergies. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, suspected COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus has become unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "borderline glaucoma" (unspecified if ongoing); "Minimal Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, After my first 2 injections, my glaucoma has increased and I'm partially blind now.), for Covid-19 immunization, reaction(s): "glaucoma has increased", "partially blind"; Bnt162b2 (DOSE 2, SINGLE, After my first 2 injections, my glaucoma has increased and I'm partially blind now.), for Covid-19 immunization, reaction(s): "glaucoma has increased", "partially blind". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus has become unbearable".  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: my hair is falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13Mar2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "my hair is falling out". Additional information: Patient was healthy before the vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 test
Clinical narrative: diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "COVID", start date: 09Mar2022 (not ongoing), notes: tested positive for COVID, COVID resolved. The patient's concomitant medications were not reported. Vaccination history included: Xeljanz (Dose 11 mg, Daily, oral, she tested positive for COVID and was instructed to hold Xeljanz, she resumed taking Xeljanz 2 weeks), administration date: 08Mar2022, for Rheumatoid arthritis. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports she started Xeljanz 08Mar2022. on 09Mar2022 she tested positive for COVID and was instructed to hold Xeljanz. COVID was "not bad", she reports she has been vaccinated and boosted. COVID resolved. she resumed taking Xeljanz 2 weeks ago and has been having diarrhea since start of therapy. she takes Xeljanz with lunch and diarrhea starts 5-6 hrs later. she has been taking Imodium with Xeljanz to manage symptoms. she is advised to update md about diarrhea and verify whether she should be taking Imodium.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: pain is moving into the patient's neck; patient cannot move arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no : 2, Batch/lot number : NA), for Covid-19 immunisation; Bnt162b2 (Dose no : 1, Batch/lot number : NA), for COVID-19 immunisation. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "pain is moving into the patient's neck"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "patient cannot move arm".  Additional information: Caller did not provide any contact information, Agent states the caller was calling on behalf of a friend, states the patient got the booster, and patient cannot move arm and pain was moving into the patient's neck. Caller states they are talking about a fourth booster, confirms of the Pfizer Covid vaccine, states her friend, the patient, got it several months ago, the first booster, and states now they are authorizing a second booster, states her friend got over the bad effect of the booster shot, states there were several days she couldn't move arm or neck, it went away after several days, states it was the same arm that had the injection, the left arm she doesnt know for sure, caller states the patient was over 50 years old and states she was concerned about getting the second booster, the fourth shot. Caller states cannot do the report, just needs to know the answers. Specifically wants to know if there was a list online of side effects or if she should get the fourth dose, the second booster. Caller declines to provide any further information. Patient sex is documented as female because the caller referred to the patient as she/her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test, Tinnitus
Clinical narrative: constant buzzing on both ears that started about 4 to ,5 months ago; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Past drug history included: Known allergies: doxicicline, reaction(s): "Known allergies: doxicicline"; Known allergies: nickel, reaction(s): "Known allergies: nickel". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. na), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. na), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 26Mar2021, outcome "unknown", described as "booster"; TINNITUS (non-serious) with onset 20Dec2021, outcome "not recovered", described as "constant buzzing on both ears that started about 4 to ,5 months ago". The event "constant buzzing on both ears that started about 4 to ,5 months ago" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: It was reported that patient have a constant buzzing on both ears that started about 4 to 5 months ago right after taking a normal shower. Saw a clinician but the sound hasn't change. The patient was treated with decongestants though she wasn't congest. The patient did not received any other vaccine in four weeks. No COVID prior vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: given expired PENTACEL vaccine to a child with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received by a health professional via call center.  This case involves a child of unknown demographics who was given expired Pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (form, strength: unknown; lot UJ4168A and expiry date: 12-Mar-2022) via unknown route in unknown administration site as prophylaxis.  On an unknown date (Latency: unknown), Nurse had given expired Pentacel vaccine to a child with no reported adverse event (expired product administered).  Action taken: Not applicable.  Event outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of ACTHIB that was administered separately with no adverse event reported; Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who experienced received an extra dose of acthib that was administered separately with no adverse event reported while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported via intramuscular route.  On an unknown date the patient developed a non-serious received an extra dose of acthib that was administered separately with no adverse event reported (extra dose administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (received an extra dose of ACTHIB that was administered separately with no adverse event reported).  Outcome: Unknown for the event received an extra dose of acthib that was administered separately with no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: she gave a 17 year old female an extra dose of IPOL by accident with no reported adverse event; Initial information received on 25-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via Nurse.  This case involves a 17 years old female adolescent patient who was given an extra dose of ipol by accident with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications includes unspecified Tuberculosis vaccines for Prophylactic vaccination.    On 23-Mar-2022, the patient received 0.5 ml (fifth dose) of suspect IPV (POLIOMYELITIS VACCINE INACTIVATED) (lot U1A452M) (strength: unknown; expiry date: 20-FEB-2023) via subcutaneous route in the left arm for Immunization. 4 other doses were administered subcutaneously at 8 weeks, 4 months, 7 months and 4 years on unknown dates for suspect IPV (VERO).  On 23-MAR-2022 the patient received an extra dose of ipol by accident with no reported adverse event (extra dose administered) following the administration of IPV (VERO).  It was reported, Pregnancy: none and Last menstrual period was on 28-Feb-2022 Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test- 0.5ML. Strength is standard except for Fluzone HD-STANDARD  Indications: Immunization or TB skin test-TB Test/Immunization.    Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of MENACTRA was inadvertently administered to a patient today with no adverse events; Initial information was received on 28-MAR-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.   This case involves a 16 years old female patient who experienced expired dose of menactra was inadvertently administered to a patient today with no adverse events while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 28-Mar-2022, the patient received  0.5 ml of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (formulation and strength: unknown) ) (lot U6874AB, expiry date- 21-FEB-2022) via intramuscular route in the right arm for Immunization.  On 28-MAR-2022 the patient developed a non-serious expired dose of menactra was inadvertently administered to a patient today with no adverse events (expired product administered) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired dose of menactra was inadvertently administered to a patient today with no adverse events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.