chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan, X-ray
Clinical narrative: Chest pain; left arm pain; left hand numbness; back pain; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 36-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch no: not reported/Lot number: EW0178) via unspecified route of administration administered in arm left on 22May2021 02:00 PM (at the age of 36-years-old) as dose 1, single for covid-19 immunization at Pharmacy or Drug Store. Medical history and concomitant medications were none. Known allergies were reported as no. No covid prior vaccination and not tested for covid post vaccination. No other vaccines taken within four weeks and no other medications in two weeks. On 24May2021 12:00 AM, patient experienced with chest pain, left arm pain, back pain, left hand numbness. No relief since more than 2 weeks. AE resulted in Emergency room/department or urgent care, which causes patient went to Emergency in (hospital name) for 8 hrs. On an unspecified date, patient underwent lab tests and procedures which included Blood test, X-ray and cardiac scan with unknown results all. No relief in symptoms. No treatment AE received for the events caused. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Pain
Clinical narrative: Pericarditis; dull pain in chest; dull pain in chest and upper back that was behind the ribs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8729), via an unspecified route of administration on 16Apr2021 at 10:00 (at the age of 46-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included gout and high cholesterol. Concomitant medications included allopurinol (ALLOPURINOL) and simvastatin (SIMVASTATIN). The patient did not receive any other vaccine in four weeks. The patient has no history of COVID-19 infection prior to vaccination, and was not tested for COVID-19 post-vaccination. On 21Apr2021 at 12:00, the patient experienced symptoms consistent with the descriptions of pericarditis as described on various websites. Initial symptom was dull pain in chest and upper back that was behind the ribs; both started on 21Apr2021 at 12:00. The pain becomes sharp when lying down. No treatment was received for the events. Outcome of the events was recovering.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Pericarditis
Clinical narrative: Pericarditis; dull pain in chest; dull pain in chest and upper back that was behind the ribs; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8729), via an unspecified route of administration on 16Apr2021 at 10:00 (at the age of 46-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included gout and high cholesterol. Concomitant medications included allopurinol (ALLOPURINOL) and simvastatin (SIMVASTATIN). The patient did not receive any other vaccine in four weeks. The patient has no history of COVID-19 infection prior to vaccination, and was not tested for COVID-19 post-vaccination. On 21Apr2021 at 12:00, the patient experienced symptoms consistent with the descriptions of pericarditis as described on various websites. Initial symptom was dull pain in chest and upper back that was behind the ribs; both started on 21Apr2021 at 12:00. The pain becomes sharp when lying down. No treatment was received for the events. Outcome of the events was recovering.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: Rash on right forearm that spread across trunk.; This is a spontaneous report from a contactable physician. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an intramuscular route of administration in the left arm on 29Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hyperlipidemia, vertigo, milk allergy . Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 07Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced rash on right forearm that spread across trunk. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with steroids (MANUFACTURER UNKNOWN) from an unknown start date to an unknown atop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on right forearm that spread across trunk was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on right forearm that spread across trunk.; This is a spontaneous report from a contactable physician. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an intramuscular route of administration in the left arm on 29Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, hyperlipidemia, vertigo, milk allergy . Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 07Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021, the patient experienced rash on right forearm that spread across trunk. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with steroids (MANUFACTURER UNKNOWN) from an unknown start date to an unknown atop date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on right forearm that spread across trunk was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Chills, Eye pain, Fatigue
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test negative, Metabolic function test, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Ear pain, Eye pain, Feeling abnormal
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Flu-line symptoms; Felt bad; Fever; Chills/Sweats; Chills/Sweats; Very achy joints; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; Sharp pains in my head in random places as well as deep in my ears and behind my eyes; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173), via an unspecified route of administration in right arm on 26May2021 at 11:00 (at the age of 43 years old) as dose 1, single for covid-19 immunisation. There was no medical history. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 28May2021 at 18:00 patient experienced flu-line symptoms have persisted now for a week. He received first dose last wednesday 26May2021 and was symptom-free for 48 hours. Then felt bad on On 28May2021 at 18:00, friday night and have had flu-like symptoms until now Tuesday afternoon. Fever, Chills/Sweats, very achy joints, sharp pains in head in random places as well as deep in ears and behind eyes. Tylenol/Ibuprofen help ease the symptoms which come back once it wears off. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 01Jun2021. The event resulted in emergency room/department or urgent care visit. No hospitalization required. The patient did not receive any treatments for the events. Reporter considered events as non-serious. The outcome of events was not recovered.  Follow-Up 30Jun2021: Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Blood test, Chest pain, Computerised tomogram
Clinical narrative: Shortness of breath with chest pain; Shortness of breath with chest pain; abdominal pain; Shortness of breath with back pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Left arm on 11May2021 15:15 at the age of 34-years-old as dose 2, single for covid-19 immunisation at Public Health Clinic/facility. Medical history included vertigo from an unknown date and supplements (supplementation therapy) on an unknown date. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken as supplement, start and stop date were not reported and iron (IRON) taken as supplement, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 20Apr2021 17:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19May2021. On 12May2021 at 04:00, the patient experienced Shortness of breath with chest pain, abdominal pain and back pain. Adverse events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Emergency treatment- medicine prescribed (steroids). The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Costochondritis, Dizziness, Dyspnoea, Fibrin D dimer increased, Headache
Clinical narrative: Shortness of breath with chest pain; Shortness of breath with chest pain; abdominal pain; Shortness of breath with back pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Left arm on 11May2021 15:15 at the age of 34-years-old as dose 2, single for covid-19 immunisation at Public Health Clinic/facility. Medical history included vertigo from an unknown date and supplements (supplementation therapy) on an unknown date. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken as supplement, start and stop date were not reported and iron (IRON) taken as supplement, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 20Apr2021 17:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19May2021. On 12May2021 at 04:00, the patient experienced Shortness of breath with chest pain, abdominal pain and back pain. Adverse events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Emergency treatment- medicine prescribed (steroids). The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia, Troponin I, Vision blurred
Clinical narrative: Shortness of breath with chest pain; Shortness of breath with chest pain; abdominal pain; Shortness of breath with back pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Left arm on 11May2021 15:15 at the age of 34-years-old as dose 2, single for covid-19 immunisation at Public Health Clinic/facility. Medical history included vertigo from an unknown date and supplements (supplementation therapy) on an unknown date. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken as supplement, start and stop date were not reported and iron (IRON) taken as supplement, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 20Apr2021 17:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19May2021. On 12May2021 at 04:00, the patient experienced Shortness of breath with chest pain, abdominal pain and back pain. Adverse events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Emergency treatment- medicine prescribed (steroids). The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Chest pain, Dyspnoea
Clinical narrative: Shortness of breath with chest pain; Shortness of breath with chest pain; abdominal pain; Shortness of breath with back pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Left arm on 11May2021 15:15 at the age of 34-years-old as dose 2, single for covid-19 immunisation at Public Health Clinic/facility. Medical history included vertigo from an unknown date and supplements (supplementation therapy) on an unknown date. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken as supplement, start and stop date were not reported and iron (IRON) taken as supplement, start and stop date were not reported received within 2 weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Left arm on 20Apr2021 17:00 (at the age of 34-years-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Device Date: 19May2021. On 12May2021 at 04:00, the patient experienced Shortness of breath with chest pain, abdominal pain and back pain. Adverse events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Emergency treatment- medicine prescribed (steroids). The outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Feeling abnormal, Headache, Hyperhidrosis, Joint stiffness
Clinical narrative: Fever 102+; sever nausea; joint stiffness; fatigue; head feels like in a fog or cloud; This is a spontaneous report received from a contactable consumer or non-health care professional (patient) and contactable health care professional reported in response to HCP letter.  A 58-year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Hospital. Medical history was not reported, and concomitant medications were none. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: EN6203) via an unspecified route of administration, administered in arm right on 09Mar2021 08:30 AM (at the age of 58-years-old) as dose 1, single for covid-19 immunization. No other vaccine taken within four weeks and no other medications taken within two weeks. Patient had no covid prior vaccination and tested for covid post vaccination. After second dose, on 01Apr2021, 03:00 AM patient experienced with Fever 102 plus, sever nausea, joint stiffness, fatigue, head feels like in a fog or cloud. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On 08Jun2021, Patient underwent lab tests and procedures which included nasal swab test for sars-Cov-2 results Negative and on 01Apr2021, Body temperature results 102 plus. Therapeutic measures taken as a result of events reported with Tylenol and rest. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Fever 102+; sever nausea; joint stiffness; fatigue; head feels like in a fog or cloud; This is a spontaneous report received from a contactable consumer or non-health care professional (patient) and contactable health care professional reported in response to HCP letter.  A 58-year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Hospital. Medical history was not reported, and concomitant medications were none. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: EN6203) via an unspecified route of administration, administered in arm right on 09Mar2021 08:30 AM (at the age of 58-years-old) as dose 1, single for covid-19 immunization. No other vaccine taken within four weeks and no other medications taken within two weeks. Patient had no covid prior vaccination and tested for covid post vaccination. After second dose, on 01Apr2021, 03:00 AM patient experienced with Fever 102 plus, sever nausea, joint stiffness, fatigue, head feels like in a fog or cloud. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On 08Jun2021, Patient underwent lab tests and procedures which included nasal swab test for sars-Cov-2 results Negative and on 01Apr2021, Body temperature results 102 plus. Therapeutic measures taken as a result of events reported with Tylenol and rest. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Joint stiffness, Nausea
Clinical narrative: Fever 102+; sever nausea; joint stiffness; fatigue; head feels like in a fog or cloud; This is a spontaneous report received from a contactable consumer or non-health care professional (patient) and contactable health care professional reported in response to HCP letter.  A 58-year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Hospital. Medical history was not reported, and concomitant medications were none. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: EN6203) via an unspecified route of administration, administered in arm right on 09Mar2021 08:30 AM (at the age of 58-years-old) as dose 1, single for covid-19 immunization. No other vaccine taken within four weeks and no other medications taken within two weeks. Patient had no covid prior vaccination and tested for covid post vaccination. After second dose, on 01Apr2021, 03:00 AM patient experienced with Fever 102 plus, sever nausea, joint stiffness, fatigue, head feels like in a fog or cloud. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On 08Jun2021, Patient underwent lab tests and procedures which included nasal swab test for sars-Cov-2 results Negative and on 01Apr2021, Body temperature results 102 plus. Therapeutic measures taken as a result of events reported with Tylenol and rest. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 102+; sever nausea; joint stiffness; fatigue; head feels like in a fog or cloud; This is a spontaneous report received from a contactable consumer or non-health care professional (patient) and contactable health care professional reported in response to HCP letter.  A 58-year-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: not reported) via an unspecified route of administration on 30Mar2021 (at the age of 58-years-old) as dose 2, single for covid-19 immunization at Hospital. Medical history was not reported, and concomitant medications were none. Historical vaccine included patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number: EN6203) via an unspecified route of administration, administered in arm right on 09Mar2021 08:30 AM (at the age of 58-years-old) as dose 1, single for covid-19 immunization. No other vaccine taken within four weeks and no other medications taken within two weeks. Patient had no covid prior vaccination and tested for covid post vaccination. After second dose, on 01Apr2021, 03:00 AM patient experienced with Fever 102 plus, sever nausea, joint stiffness, fatigue, head feels like in a fog or cloud. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On 08Jun2021, Patient underwent lab tests and procedures which included nasal swab test for sars-Cov-2 results Negative and on 01Apr2021, Body temperature results 102 plus. Therapeutic measures taken as a result of events reported with Tylenol and rest. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Headache, Malaise, Odynophagia
Clinical narrative: Neck swelling; pain with difficulty swallowing to solids and liquids including saliva; pain with difficulty swallowing to solids and liquids including saliva; I was very uncomfortable; Tinnitus; fatigue; headaches; malaise; This is a spontaneous report from a contactable physician. A 46-years-old non pregnant female patient herself reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0181, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:30 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included ulcerative colitis from an unknown date and unknown if ongoing, penicillin from an unknown date and unknown if ongoing. On 17Jun2021 the patient experienced Neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot she was very uncomfortable and called the on call physician for her doctor. She was already taking acetaminophen for her symptoms physician recommended adding an antihistamine. She started Zyrtec once daily with a mild transient improvement in her symptoms. On day 2 after the shot she woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. She also experienced fatigue, headaches and malaise on days one, two and three after the shot. Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient received for the treatment for events. The outcome of events fatigue, headaches and malaise was recovered by day four on 21Jun2021. The outcome of events neck swelling, pain with difficulty swallowing to solids and liquids including saliva, pain with difficulty swallowing to solids and liquids including saliva, she was very uncomfortable, Tinnitus was not recovered.     Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Tinnitus
Clinical narrative: Neck swelling; pain with difficulty swallowing to solids and liquids including saliva; pain with difficulty swallowing to solids and liquids including saliva; I was very uncomfortable; Tinnitus; fatigue; headaches; malaise; This is a spontaneous report from a contactable physician. A 46-years-old non pregnant female patient herself reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0181, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:30 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included ulcerative colitis from an unknown date and unknown if ongoing, penicillin from an unknown date and unknown if ongoing. On 17Jun2021 the patient experienced Neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot she was very uncomfortable and called the on call physician for her doctor. She was already taking acetaminophen for her symptoms physician recommended adding an antihistamine. She started Zyrtec once daily with a mild transient improvement in her symptoms. On day 2 after the shot she woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. She also experienced fatigue, headaches and malaise on days one, two and three after the shot. Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient received for the treatment for events. The outcome of events fatigue, headaches and malaise was recovered by day four on 21Jun2021. The outcome of events neck swelling, pain with difficulty swallowing to solids and liquids including saliva, pain with difficulty swallowing to solids and liquids including saliva, she was very uncomfortable, Tinnitus was not recovered.     Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: Neck swelling; pain with difficulty swallowing to solids and liquids including saliva; pain with difficulty swallowing to solids and liquids including saliva; I was very uncomfortable; Tinnitus; fatigue; headaches; malaise; This is a spontaneous report from a contactable physician. A 46-years-old non pregnant female patient herself reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0181, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:30 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included ulcerative colitis from an unknown date and unknown if ongoing, penicillin from an unknown date and unknown if ongoing. On 17Jun2021 the patient experienced Neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot she was very uncomfortable and called the on call physician for her doctor. She was already taking acetaminophen for her symptoms physician recommended adding an antihistamine. She started Zyrtec once daily with a mild transient improvement in her symptoms. On day 2 after the shot she woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. She also experienced fatigue, headaches and malaise on days one, two and three after the shot. Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient received for the treatment for events. The outcome of events fatigue, headaches and malaise was recovered by day four on 21Jun2021. The outcome of events neck swelling, pain with difficulty swallowing to solids and liquids including saliva, pain with difficulty swallowing to solids and liquids including saliva, she was very uncomfortable, Tinnitus was not recovered.     Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Odynophagia, Swelling, Tinnitus
Clinical narrative: Neck swelling; pain with difficulty swallowing to solids and liquids including saliva; pain with difficulty swallowing to solids and liquids including saliva; I was very uncomfortable; Tinnitus; fatigue; headaches; malaise; This is a spontaneous report from a contactable physician. A 46-years-old non pregnant female patient herself reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EW0181, Expiry date: unknown) via an unspecified route of administration, administered in Arm Left on 16Jun2021 14:30 (at the age of 46-years-old) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included ulcerative colitis from an unknown date and unknown if ongoing, penicillin from an unknown date and unknown if ongoing. On 17Jun2021 the patient experienced Neck swelling, and pain with difficulty swallowing to solids and liquids including saliva. The symptoms began the day after the shot and became worse each day. On the third day after the shot she was very uncomfortable and called the on call physician for her doctor. She was already taking acetaminophen for her symptoms physician recommended adding an antihistamine. She started Zyrtec once daily with a mild transient improvement in her symptoms. On day 2 after the shot she woke up with tinnitus in both ears that has been constant since it began, especially prominent in the morning and most noticeable in quieter surroundings but constantly there in the background. She also experienced fatigue, headaches and malaise on days one, two and three after the shot. Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient received for the treatment for events. The outcome of events fatigue, headaches and malaise was recovered by day four on 21Jun2021. The outcome of events neck swelling, pain with difficulty swallowing to solids and liquids including saliva, pain with difficulty swallowing to solids and liquids including saliva, she was very uncomfortable, Tinnitus was not recovered.     Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Mouth swelling, Swelling face, Swollen tongue
Clinical narrative: My face is bit of swollen; I have rash on my back; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received bnt162b2 (BNT162B2) solution for injection, dose 1 (Batch/Lot Number: ER8736) via an unspecified route of administration on 18Jun2021 (at the age of 58-years-old) as dose 1 single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Concomitant Medication: consumer stated, "She knows all the medicine that she is taking. She cannot remember so that's what she saying this was she need her doctor to pronounce this, she can't pronounce this actually." (Further not clarified hence not captured in tab however yes was checked in tab). Consumer stated, "she calling to report a reaction from the COVID Vaccination. Consumer confirmed that it was Pfizer COVID 19 Vaccine. Consumer stated, "she took the shot Friday, and she woke up this morning and her face was bit of swollen and she had rash on her back. When paraphrased the above concern, Consumer stated, "No her back was not swollen she woke up this morning her face is swollen and her back has rash on it. Email address: Consumer stated, "she doesn't have one. LOT#: Consumer stated, "First dose COVID, ER8736. Expiration date: Consumer stated, "No, there is not an expiration date on it. I just get it Friday." Date of administration: Consumer stated, "6th month 18day 2021 (18Jun2021). Schedule for second dose: Consumer stated, "she hasn't got the date, it's in 3 weeks. Outcome of event: Consumer stated, they said its most likely to have a side effect, yeah, they told her when she took the shot that it's going to have some side effects, it could be the swelling of the face or so, when she does have one to call and report it so that's what her doing. Outcome of the events was unknown   No follow-up attempts are needed. No further information is expected.   Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.