chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested covid-19 positive; Tested covid-19 positive; headache; cough; flu body feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested covid-19 positive"; HEADACHE (non-serious), outcome "unknown", described as "headache"; COUGH (non-serious), outcome "unknown", described as "cough"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu body feeling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Tested covid-19 positive two months after booster shot (3rd shot).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Electrocardiogram abnormal, Neck pain, Pain
Clinical narrative: Heart attack symptoms; Abnormal Echo; Abnormal ECG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:30 (Lot number: FJ8757) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 25Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 15Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 12Dec2021 17:30, outcome "not recovered", described as "Heart attack symptoms"; ECHOCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal Echo"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal ECG". The events "heart attack symptoms", "abnormal echo" and "abnormal ecg" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (12Dec2021) abnormal; electrocardiogram: (12Dec2021) abnormal; investigation: (unspecified date) unknown results. Therapeutic measures were taken as a result of myocardial infarction, echocardiogram abnormal, electrocardiogram abnormal. Clinical course: Patient had not received any  other vaccines in four weeks. Patient not  had covid prior vaccination. Patient was not tested covid post vaccination. No Known allergies. AE treatment: Several tests and now seeing Cardiologist.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Heart attack symptoms; Abnormal Echo; Abnormal ECG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:30 (Lot number: FJ8757) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 25Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 15Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 12Dec2021 17:30, outcome "not recovered", described as "Heart attack symptoms"; ECHOCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal Echo"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal ECG". The events "heart attack symptoms", "abnormal echo" and "abnormal ecg" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (12Dec2021) abnormal; electrocardiogram: (12Dec2021) abnormal; investigation: (unspecified date) unknown results. Therapeutic measures were taken as a result of myocardial infarction, echocardiogram abnormal, electrocardiogram abnormal. Clinical course: Patient had not received any  other vaccines in four weeks. Patient not  had covid prior vaccination. Patient was not tested covid post vaccination. No Known allergies. AE treatment: Several tests and now seeing Cardiologist.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Echocardiogram abnormal, Electrocardiogram, Electrocardiogram abnormal, Investigation
Clinical narrative: Heart attack symptoms; Abnormal Echo; Abnormal ECG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:30 (Lot number: FJ8757) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 25Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 15Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 12Dec2021 17:30, outcome "not recovered", described as "Heart attack symptoms"; ECHOCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal Echo"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal ECG". The events "heart attack symptoms", "abnormal echo" and "abnormal ecg" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (12Dec2021) abnormal; electrocardiogram: (12Dec2021) abnormal; investigation: (unspecified date) unknown results. Therapeutic measures were taken as a result of myocardial infarction, echocardiogram abnormal, electrocardiogram abnormal. Clinical course: Patient had not received any  other vaccines in four weeks. Patient not  had covid prior vaccination. Patient was not tested covid post vaccination. No Known allergies. AE treatment: Several tests and now seeing Cardiologist.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack symptoms; Abnormal Echo; Abnormal ECG; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 17:30 (Lot number: FJ8757) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 25Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Vaccine Administration Time: 05:30 PM, Location of injection: Left Arm), administration date: 15Apr2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 12Dec2021 17:30, outcome "not recovered", described as "Heart attack symptoms"; ECHOCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal Echo"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 12Dec2021 17:30, outcome "not recovered", described as "Abnormal ECG". The events "heart attack symptoms", "abnormal echo" and "abnormal ecg" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (12Dec2021) abnormal; electrocardiogram: (12Dec2021) abnormal; investigation: (unspecified date) unknown results. Therapeutic measures were taken as a result of myocardial infarction, echocardiogram abnormal, electrocardiogram abnormal. Clinical course: Patient had not received any  other vaccines in four weeks. Patient not  had covid prior vaccination. Patient was not tested covid post vaccination. No Known allergies. AE treatment: Several tests and now seeing Cardiologist.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Cardiac stress test, Chest X-ray, Chest discomfort
Clinical narrative: Very Heavy heart beat; palpitations; shortness of breath; tired; sleeplessness; irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 17:00 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception; ZINC; ELDERBERRY [SAMBUCUS NIGRA]. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "Very Heavy heart beat"; PALPITATIONS (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "palpitations"; DYSPNOEA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "shortness of breath"; FATIGUE (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "tired"; INSOMNIA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "sleeplessness"; IRRITABILITY (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "irritable". The events "very heavy heart beat", "palpitations", "shortness of breath", "tired", "sleeplessness" and "irritable" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, palpitations, dyspnoea, fatigue, insomnia, irritability.  Additional information:  No Known allergies. The patient did not receive any other vaccines within 4 weeks. The patient received other medications multivitamin within 2 weeks. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased, Inner ear disorder
Clinical narrative: Very Heavy heart beat; palpitations; shortness of breath; tired; sleeplessness; irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 17:00 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception; ZINC; ELDERBERRY [SAMBUCUS NIGRA]. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "Very Heavy heart beat"; PALPITATIONS (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "palpitations"; DYSPNOEA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "shortness of breath"; FATIGUE (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "tired"; INSOMNIA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "sleeplessness"; IRRITABILITY (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "irritable". The events "very heavy heart beat", "palpitations", "shortness of breath", "tired", "sleeplessness" and "irritable" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, palpitations, dyspnoea, fatigue, insomnia, irritability.  Additional information:  No Known allergies. The patient did not receive any other vaccines within 4 weeks. The patient received other medications multivitamin within 2 weeks. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Sleep disorder
Clinical narrative: Very Heavy heart beat; palpitations; shortness of breath; tired; sleeplessness; irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 17:00 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception; ZINC; ELDERBERRY [SAMBUCUS NIGRA]. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "Very Heavy heart beat"; PALPITATIONS (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "palpitations"; DYSPNOEA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "shortness of breath"; FATIGUE (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "tired"; INSOMNIA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "sleeplessness"; IRRITABILITY (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "irritable". The events "very heavy heart beat", "palpitations", "shortness of breath", "tired", "sleeplessness" and "irritable" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, palpitations, dyspnoea, fatigue, insomnia, irritability.  Additional information:  No Known allergies. The patient did not receive any other vaccines within 4 weeks. The patient received other medications multivitamin within 2 weeks. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate, Heart rate irregular, Insomnia
Clinical narrative: Very Heavy heart beat; palpitations; shortness of breath; tired; sleeplessness; irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 17:00 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception; ZINC; ELDERBERRY [SAMBUCUS NIGRA]. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "Very Heavy heart beat"; PALPITATIONS (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "palpitations"; DYSPNOEA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "shortness of breath"; FATIGUE (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "tired"; INSOMNIA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "sleeplessness"; IRRITABILITY (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "irritable". The events "very heavy heart beat", "palpitations", "shortness of breath", "tired", "sleeplessness" and "irritable" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, palpitations, dyspnoea, fatigue, insomnia, irritability.  Additional information:  No Known allergies. The patient did not receive any other vaccines within 4 weeks. The patient received other medications multivitamin within 2 weeks. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Palpitations
Clinical narrative: Very Heavy heart beat; palpitations; shortness of breath; tired; sleeplessness; irritable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 17:00 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: APRI taken for contraception; ZINC; ELDERBERRY [SAMBUCUS NIGRA]. The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "Very Heavy heart beat"; PALPITATIONS (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "palpitations"; DYSPNOEA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "shortness of breath"; FATIGUE (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "tired"; INSOMNIA (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "sleeplessness"; IRRITABILITY (non-serious) with onset 18Sep2021 22:00, outcome "not recovered", described as "irritable". The events "very heavy heart beat", "palpitations", "shortness of breath", "tired", "sleeplessness" and "irritable" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate irregular, palpitations, dyspnoea, fatigue, insomnia, irritability.  Additional information:  No Known allergies. The patient did not receive any other vaccines within 4 weeks. The patient received other medications multivitamin within 2 weeks. No treatment was received to the response of adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Lip swelling, Myalgia, Pyrexia, Swelling face
Clinical narrative: Generalized hives; facial/lip/ear swelling; facial/lip/ear swelling; facial/lip/ear swelling; generalized muscle pain; fever; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Feb2022 16:00 (Lot number: FK5618) at the age of 9 years as dose 2, (tris) single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; ZYRTEC ALLERGY. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM, Route of Administration: Intramuscular), administration date: 11Jan2022, when the patient was 9 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "Generalized hives"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), EAR SWELLING (non-serious) all with onset 02Feb2022 15:00, outcome "recovering" and all described as "facial/lip/ear swelling"; MYALGIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "generalized muscle pain"; PYREXIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "fever". The events "generalized hives", "facial/lip/ear swelling", "facial/lip/ear swelling", "facial/lip/ear swelling", "generalized muscle pain" and "fever" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, swelling face, lip swelling, ear swelling, myalgia, pyrexia. Additional information: Patient received treatment for the adverse event with Benadryl. She did not receive any other vaccine within 4 weeks prior to COVID vaccination. She was not tested positive for COVID prior to vaccination and was not tested positive since the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Generalized hives; facial/lip/ear swelling; facial/lip/ear swelling; facial/lip/ear swelling; generalized muscle pain; fever; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Feb2022 16:00 (Lot number: FK5618) at the age of 9 years as dose 2, (tris) single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; ZYRTEC ALLERGY. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM, Route of Administration: Intramuscular), administration date: 11Jan2022, when the patient was 9 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "Generalized hives"; SWELLING FACE (non-serious), LIP SWELLING (non-serious), EAR SWELLING (non-serious) all with onset 02Feb2022 15:00, outcome "recovering" and all described as "facial/lip/ear swelling"; MYALGIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "generalized muscle pain"; PYREXIA (non-serious) with onset 02Feb2022 15:00, outcome "recovering", described as "fever". The events "generalized hives", "facial/lip/ear swelling", "facial/lip/ear swelling", "facial/lip/ear swelling", "generalized muscle pain" and "fever" were evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, swelling face, lip swelling, ear swelling, myalgia, pyrexia. Additional information: Patient received treatment for the adverse event with Benadryl. She did not receive any other vaccine within 4 weeks prior to COVID vaccination. She was not tested positive for COVID prior to vaccination and was not tested positive since the vaccination. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 16:45 (Lot number: EW0178) at the age of 30 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: IRON; FLUOXETINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Jul2021 17:00, outcome "recovered" (20Aug2021), described as "Pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: 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 multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 16:45 (Lot number: EW0178) at the age of 30 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Shellfish allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: IRON; FLUOXETINE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Jul2021 17:00, outcome "recovered" (20Aug2021), described as "Pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: 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 multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Sore Arm; Mild elevated temperature; felt off; 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 left, administration date 07Sep2021 (Lot number: FC3183) at the age of 61 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "super clavicular tachycardia" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing), notes: Verbatim: Breast cancer, Left Breast; "Allergy: Macrobid" (unspecified if ongoing), notes: allergic to Macrobid; "Allergy: sulfa" (unspecified if ongoing), notes: sulfa products; "Allergy: Bee venom" (unspecified if ongoing), notes: its a mild reaction, nothing deathly as of yet. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: First dose, Lot number: EN6208, Administered in the Right Arm), administration date: 10Mar2021, for COVID-19 immunization; Bnt162b2 (Dose number: Second dose, Lot number: EN6208, Administered in the Right Arm), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 08Sep2021, outcome "recovered" (11Sep2021), described as "Mild elevated temperature"; FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "recovered" (11Sep2021), described as "felt off".  Additional Information: The patient had 3 doses in total. She had the first 2 and then the 3rd booster, which she got because of her history. The first 2 shots were simple. With the 3rd dose she had a sore arm 24 hours later for 4 days, she also had a mild elevated temperature, her temperature was between half a degree to a degree from her usual normal temperature, during the time her temperature was elevated she also felt off, like she had a fever, but she was not totally knocked down, this was for 4 to 4 and half days. Concomitant Medication: Nothing new from what she was already taking.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Feeling abnormal, Pain in extremity
Clinical narrative: Sore Arm; Mild elevated temperature; felt off; 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 left, administration date 07Sep2021 (Lot number: FC3183) at the age of 61 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "super clavicular tachycardia" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing), notes: Verbatim: Breast cancer, Left Breast; "Allergy: Macrobid" (unspecified if ongoing), notes: allergic to Macrobid; "Allergy: sulfa" (unspecified if ongoing), notes: sulfa products; "Allergy: Bee venom" (unspecified if ongoing), notes: its a mild reaction, nothing deathly as of yet. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: First dose, Lot number: EN6208, Administered in the Right Arm), administration date: 10Mar2021, for COVID-19 immunization; Bnt162b2 (Dose number: Second dose, Lot number: EN6208, Administered in the Right Arm), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm"; BODY TEMPERATURE INCREASED (non-serious) with onset 08Sep2021, outcome "recovered" (11Sep2021), described as "Mild elevated temperature"; FEELING ABNORMAL (non-serious) with onset 08Sep2021, outcome "recovered" (11Sep2021), described as "felt off".  Additional Information: The patient had 3 doses in total. She had the first 2 and then the 3rd booster, which she got because of her history. The first 2 shots were simple. With the 3rd dose she had a sore arm 24 hours later for 4 days, she also had a mild elevated temperature, her temperature was between half a degree to a degree from her usual normal temperature, during the time her temperature was elevated she also felt off, like she had a fever, but she was not totally knocked down, this was for 4 to 4 and half days. Concomitant Medication: Nothing new from what she was already taking.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Malaise, Vaccination site pain
Clinical narrative: Fatigue/extreme tiredness; Muscle Aches; Lethargic; malaise/not feeling well; pain in arm/Arm tenderness; Missed work; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Colon cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for Covid-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Fatigue/extreme tiredness"; MYALGIA (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Muscle Aches"; LETHARGY (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "recovered" (2021), described as "pain in arm/Arm tenderness"; MALAISE (non-serious) with onset 28Sep2021, outcome "recovered" (30Sep2021), described as "malaise/not feeling well"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Missed work". It was unknown if therapeutic measures were taken as a result of fatigue, myalgia, lethargy. Therapeutic measures were not taken as a result of pain in extremity, malaise.  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: I have filed 2 reports in the last 30 days. Can you provide my original submission so I can complete this form?  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: The document indicates that a password is required.  Follow up (05Oct2021):This is a follow up spontaneous report from a contactable Pharmacist. This Pharmacist reported for 53-year-old female patient in response to consumer letter send via follow-up that includes:Sorry but my document feeder wasn't working on the scanner. Comments/Narrative:patient received vaccine and complained of arm tenderness on day1.On day 2 complained of not feeling well and extreme tiredness. missed work.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Loss of personal independence in daily activities, Malaise, Myalgia
Clinical narrative: Fatigue/extreme tiredness; Muscle Aches; Lethargic; malaise/not feeling well; pain in arm/Arm tenderness; Missed work; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Colon cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for Covid-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Fatigue/extreme tiredness"; MYALGIA (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Muscle Aches"; LETHARGY (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "recovered" (2021), described as "pain in arm/Arm tenderness"; MALAISE (non-serious) with onset 28Sep2021, outcome "recovered" (30Sep2021), described as "malaise/not feeling well"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Missed work". It was unknown if therapeutic measures were taken as a result of fatigue, myalgia, lethargy. Therapeutic measures were not taken as a result of pain in extremity, malaise.  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: I have filed 2 reports in the last 30 days. Can you provide my original submission so I can complete this form?  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: The document indicates that a password is required.  Follow up (05Oct2021):This is a follow up spontaneous report from a contactable Pharmacist. This Pharmacist reported for 53-year-old female patient in response to consumer letter send via follow-up that includes:Sorry but my document feeder wasn't working on the scanner. Comments/Narrative:patient received vaccine and complained of arm tenderness on day1.On day 2 complained of not feeling well and extreme tiredness. missed work.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue/extreme tiredness; Muscle Aches; Lethargic; malaise/not feeling well; pain in arm/Arm tenderness; Missed work; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm, administration date 27Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Colon cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2), for Covid-19 immunization; Bnt162b2 (Dose:1), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Fatigue/extreme tiredness"; MYALGIA (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Muscle Aches"; LETHARGY (non-serious) with onset 28Sep2021, outcome "recovered" (Sep2021), described as "Lethargic"; PAIN IN EXTREMITY (non-serious) with onset 27Sep2021, outcome "recovered" (2021), described as "pain in arm/Arm tenderness"; MALAISE (non-serious) with onset 28Sep2021, outcome "recovered" (30Sep2021), described as "malaise/not feeling well"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Missed work". It was unknown if therapeutic measures were taken as a result of fatigue, myalgia, lethargy. Therapeutic measures were not taken as a result of pain in extremity, malaise.  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: I have filed 2 reports in the last 30 days. Can you provide my original submission so I can complete this form?  Follow up (04Oct2021):This is a follow up spontaneous report from a contactable consumer. This consumer reported that: The document indicates that a password is required.  Follow up (05Oct2021):This is a follow up spontaneous report from a contactable Pharmacist. This Pharmacist reported for 53-year-old female patient in response to consumer letter send via follow-up that includes:Sorry but my document feeder wasn't working on the scanner. Comments/Narrative:patient received vaccine and complained of arm tenderness on day1.On day 2 complained of not feeling well and extreme tiredness. missed work.  Follow-up (11Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: difficulty sleeping; pain/discomfort from back of the elbow to shoulder and up to neck on left side.; pain in arm; pain from shoulder to elbow; discomfort from elbow to shoulder and neck; injection far back on arm; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 15th February 2022, the patient experienced shoulder pain, neck discomfort, neck pain and pain in arm. On an unknown date, the patient experienced difficulty sleeping. On an unknown date, the outcome of the shoulder pain and neck discomfort were not recovered/not resolved and the outcome of the difficulty sleeping, neck pain, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, neck discomfort, difficulty sleeping, neck pain and pain in arm to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. The registered pharmacist gave Shingrix injection on the back of the left arm, which led to vaccine administered at inappropriate site.  The patient never received an injection that far back on arm before. Next day after vaccination, the patient had pain or discomfort from back of the elbow to shoulder and up to neck on left side.  The patient reached out to registered pharmacist the day after he gave her vaccine, to report pain in arm and was told to use ice. After a week of no relief, the patient called her pain management healthcare professional.  Less than a month after receiving Shingrix, the patient experienced difficulty in sleeping. He gave her 2 pain shots, patient felt better but still had some discomfort. The patient was referred to healthcare professional.   Consent to follow up was given.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Insomnia, Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: difficulty sleeping; pain/discomfort from back of the elbow to shoulder and up to neck on left side.; pain in arm; pain from shoulder to elbow; discomfort from elbow to shoulder and neck; injection far back on arm; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th February 2022, the patient received the 1st dose of Shingrix. On 14th February 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 15th February 2022, the patient experienced shoulder pain, neck discomfort, neck pain and pain in arm. On an unknown date, the patient experienced difficulty sleeping. On an unknown date, the outcome of the shoulder pain and neck discomfort were not recovered/not resolved and the outcome of the difficulty sleeping, neck pain, pain in arm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, neck discomfort, difficulty sleeping, neck pain and pain in arm to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was unknown. The registered pharmacist gave Shingrix injection on the back of the left arm, which led to vaccine administered at inappropriate site.  The patient never received an injection that far back on arm before. Next day after vaccination, the patient had pain or discomfort from back of the elbow to shoulder and up to neck on left side.  The patient reached out to registered pharmacist the day after he gave her vaccine, to report pain in arm and was told to use ice. After a week of no relief, the patient called her pain management healthcare professional.  Less than a month after receiving Shingrix, the patient experienced difficulty in sleeping. He gave her 2 pain shots, patient felt better but still had some discomfort. The patient was referred to healthcare professional.   Consent to follow up was given.