chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal injury
Clinical narrative: Paralyzed legs; Broke his nose; Experiencing insulin resistance/feels like his insulin is not working; Fall; Hypoglycemic; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (type 1). Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes mellitus, LISINOPRIL, GABAPENTIN, CYCLOBENZAPRINE, ATORVASTATIN, OXYCODONE, OMEPRAZOLE and GLUCAGON (BAQSIMI) for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLEGIA (Paralyzed legs) (seriousness criteria medically significant and life threatening), NASAL INJURY (Broke his nose) (seriousness criterion life threatening), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working) (seriousness criteria medically significant and life threatening), FALL (Fall) (seriousness criterion life threatening) and HYPOGLYCAEMIA (Hypoglycemic) (seriousness criterion life threatening). At the time of the report, DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 500 (High) High.         The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.  Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.; Sender's Comments: Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Facial bones fracture, Fall, Hypoglycaemia, Monoplegia
Clinical narrative: Experienced paralyzed legs; Broke his nose; Hypoglycemic; Caused a fall,fell few times after; This spontaneous case was reported by a health care professional and describes the occurrence of MONOPLEGIA (Experienced paralyzed legs), FACIAL BONES FRACTURE (Broke his nose), HYPOGLYCAEMIA (Hypoglycemic) and FALL (Caused a fall,fell few times after) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044H21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG), LISINOPRIL, GABAPENTIN, CYCLOBENZAPRINE, ATORVASTATIN, OXYCODONE, OMEPRAZOLE and GLUCAGON (BAQSIMI) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (Experienced paralyzed legs) (seriousness criteria medically significant and life threatening), FACIAL BONES FRACTURE (Broke his nose) (seriousness criteria medically significant and life threatening), HYPOGLYCAEMIA (Hypoglycemic) (seriousness criterion life threatening) and FALL (Caused a fall,fell few times after) (seriousness criterion life threatening). At the time of the report, MONOPLEGIA (Experienced paralyzed legs), FACIAL BONES FRACTURE (Broke his nose), HYPOGLYCAEMIA (Hypoglycemic) and FALL (Caused a fall,fell few times after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) his blood sugar is going up and blood glucose is around 500 after using his insulin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported.  Patient  experiencing insulin resistance, feels like his insulin was not working and  his blood sugar was going up. He stated that his blood glucose was around 500 after using his insulin which never used be like that until he got his second dose of the Moderna COVID-19 Vaccine  and still ongoing as of today. He had hypoglycemic emergency and  fell few times after second shot, Patient also experienced paralyzed legs which caused a fall and  broke his nose. Patient never went to hospital and taped his nose since it was  not  extreme. Concomitant medications included Insulin Novolog  1-30 units on sliding scale.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded   This case was linked to MOD-2021-115467 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted twice; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted twice) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainted twice) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainted twice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  No treatment information was provided.  It was reported that, the patient took Moderna vaccine the previous day and at present morning fainted twice.  Company Comment : Very limited information regarding this case. However, based on the current available information from the case narrative and temporal association between the use of the product connected to the event, a causal relationship cannot be excluded.     Reporter did not allow further contact; Sender's Comments: Very limited information regarding this case. However, based on the current available information from the case narrative and temporal association between the use of the product connected to the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Unconscious; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present, Nephrolithiasis
Clinical narrative: Kidney stone; pissing blood; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant) and BLOOD URINE PRESENT (pissing blood   ). At the time of the report, NEPHROLITHIASIS (Kidney stone) and BLOOD URINE PRESENT (pissing blood   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Cough, Electrocardiogram, Pericarditis
Clinical narrative: pericarditis; severe chest pain; It was worse when laid down; It felt like angina, like heart attack; I'm still short of breath; dry cough; This spontaneous case was reported by a nurse and describes the occurrence of ANGINA PECTORIS (It felt like angina, like heart attack), PERICARDITIS (pericarditis), CHEST PAIN (severe chest pain), CHEST DISCOMFORT (It was worse when laid down) and DYSPNOEA (I'm still short of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus and Renal disease (Genetic).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced ANGINA PECTORIS (It felt like angina, like heart attack) (seriousness criteria hospitalization and medically significant), CHEST PAIN (severe chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (It was worse when laid down) (seriousness criterion hospitalization) and COUGH (dry cough). On 25-Jun-2021, the patient experienced DYSPNOEA (I'm still short of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, ANGINA PECTORIS (It felt like angina, like heart attack), PERICARDITIS (pericarditis), CHEST PAIN (severe chest pain), CHEST DISCOMFORT (It was worse when laid down), DYSPNOEA (I'm still short of breath) and COUGH (dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: textbook for pericarditis (abnormal) cardiologist described her EKG as textbook for pericarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details was provided. The Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.  Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: tingling sensation along recent surgical incision and along both sides; Burning pain down left leg from knee to foot; This is a spontaneous report from non-contactable or other healthcare professional. A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration on 17Mar2021 (at the age of 49 years old) as a single dose for COVID-19 immunization. Medical history includes full knee replacement on 09Mar2021. Concomitant drugs include were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot no: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. On 17Mar2021 after 15minutes waiting period of the vaccination, the patient experienced tingling sensation along recent surgical incision and along both sides, and burning pain down left leg from knee to foot. The patient did not receive treatment for the reported event. The left knee was bandaged, wrapped with ace bandage and also had compression socks on. The clinical outcome of tingling sensation and burning pain was unknown.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient's name and country added in patient tab; and Treatment Received ticked Yes.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: waking up at 4am with aches and some nausea; waking up at 4am with aches and some nausea; experiencing some chills; This is a spontaneous report received from a contactable consumer. A 41-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021 at 12:00 (at the age of 41-year-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 04:00, the patient woke up with aches, some nausea and experiencing some chills. It was unknown if the patient received any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events aches, nausea and chills were resolved on an unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event ache, nausea description updated to waking up at 4am with aches and some nausea, Event chills description updated to experiencing some chills, Final sentence in analysis tab updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Dry cough; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6208), via an unspecified route of administration in left arm on 17Mar2021 at 15:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation at Health Department. The patient had no medical history and no known allergies to medications, food, or other products. Concomitant medication included cetirizine hydrochloride (ALLERTEC) (received within 2 weeks of vaccination). The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200), via an unspecified route of administration on 24Feb2021 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021, the patient experienced dry cough. Patient did not receive any treatment for the event. The patient underwent Covid-19 test (nasal swab test) on an unknown date in 2021 and the test result was negative. The outcome of dry cough was recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added reporter details, historical vaccine age and clinical course. Medical history, patient initials, concomitant medication, lab test date, second dose details and event treatment details were updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Chills; joint pain; slight fever; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via unspecified route of administration on 17Mar2021 (52-year-old at the time of vaccination) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 18Mar2021, the patient developed chills, joint pain and slight fever. The patient did not receive any treatment for events. The clinical outcome of the events was resolved on unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's age and age at vaccination (52-year-old), and lead sentence in analysis tab was updated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm. Started about 5 hours after injection.; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other medication within two weeks prior to the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced sore arm started about 5 hours after injection. The clinical outcome of the sore arm started about 5 hours after injection was not recovered.  Amendment: This follow up is being submitted to amend previously reported information: State leave blank for reporter and patient since no state provided in source. Final sentence updated to No follow-up attempts are possible.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Oropharyngeal pain, Photophobia, Seasonal allergy
Clinical narrative: light sensitivity; fatigue; increase in hay fever symptoms; post nasal drip, sore throat; injection site soreness; post nasal drip; sore throat + lymph nodes around jaw; This is a spontaneous report received from a non-contactable other health care professional. An 18-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 18-year-old) as a single dose for COVID-19 immunization. Medical history included eczema. The patient was allergic to pistachio and had hay fever allergy. The patient previously had taken fluoxetine, retinoids and had experienced allergy. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 09:30, the patient experienced light sensitivity, fatigue, increase in hay fever symptoms, post nasal drip, sore throat and lymph nodes around jaw, injection site soreness (24+ hours). Therapeutic measures included extra dose zyrtec allergy pill, ibuprofen and rest. The clinical outcome of light sensitivity, fatigue, increase in hay fever symptoms, postnasal drip, sore throat and lymph nodes around jaw, injection site soreness was unknown at the time of report.   Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial added in first name field in patient tab.  2. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome, Vaccination site pain
Clinical narrative: light sensitivity; fatigue; increase in hay fever symptoms; post nasal drip, sore throat; injection site soreness; post nasal drip; sore throat + lymph nodes around jaw; This is a spontaneous report received from a non-contactable other health care professional. An 18-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (at the age of 18-year-old) as a single dose for COVID-19 immunization. Medical history included eczema. The patient was allergic to pistachio and had hay fever allergy. The patient previously had taken fluoxetine, retinoids and had experienced allergy. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Mar2021 at 09:30, the patient experienced light sensitivity, fatigue, increase in hay fever symptoms, post nasal drip, sore throat and lymph nodes around jaw, injection site soreness (24+ hours). Therapeutic measures included extra dose zyrtec allergy pill, ibuprofen and rest. The clinical outcome of light sensitivity, fatigue, increase in hay fever symptoms, postnasal drip, sore throat and lymph nodes around jaw, injection site soreness was unknown at the time of report.   Amendment: This follow-up report is being submitted to amend previously reported information: 1. patient's initial added in first name field in patient tab.  2. final sentence updated to No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Light headedness; nausea; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 02Mar2021 11:00 in left arm (Lot number EN6203), at the age of 32-years-old, as a single dose (dose number unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 15:00, the patient experienced light headedness and nausea which set in about 4hours after the vaccine was administered and lasted for around 3-4hours before going away. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of light headedness and nausea was recovered on 02Mar2021 at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination administration time (11:00 am), stop date of events (02Mar2021) and vaccination facility information were added.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Product use issue, Pyrexia, Rash
Clinical narrative: Neck rash; temperature spike lasting 3 minutes; Hot flash; patient received bnt162b2 on 24Mar2021, and also had other vaccine on same day; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via unspecified route of administration in left arm on 24Mar2021 at 14:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included hypercalcemia. It was reported that the patient was allergic to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other medications within two weeks of vaccination. Patient concomitant medications were not reported. Patient also had other vaccine on 24Mar2021. On 24Mar2021 at 14:30, the patient experienced neck rash, and very hot 'hot flash' temperature spike lasting 3 minutes. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of neck rash, hot flash and temperature spike lasting 3 minutes were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: vaccination facility information updated, added new event product use for unapproved combination.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dizziness, Heart rate, Heart rate increased
Clinical narrative: Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Sore / achy; Feverish; Chills; red and tender swollen injection site; red and tender swollen injection site; red and tender swollen injection site; Lightheaded; swollen and tender armpit glands,; Elevated heart rate; swollen and tender armpit glands; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: er8735) via an unspecified route of administration on 26Apr2021(at the age of 26 years old) as a single dose, for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications were not reported. The patient reported that his past drug history included dairy (unspecified). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands and elevated heart rate on 26Apr2021. The patient did not receive any treatment for the events. The clinical outcome of the events sore / achy, feverish, chills, red and tender swollen injection site, lightheaded, swollen and tender armpit glands, elevated heart rate were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient email address added, medical history added (known allergies: dairy), treatment received was ticked as No and updated narrative.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 23-year-old-female non pregnant patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on 28Apr2021 at 00:00 (at the age of 23-year-old), for COVID-19 immunisation. Medical history of the patient and concomitant medications was not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. On unknown date the patient experienced diarrhea. The clinical outcome of the event diarrhea was unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report was being submitted to amend previously reported information: The start and stop date/time of BNT162B2 were updated as 28Aapr2021 00:00.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: ITP platelet count of 32,000; This is a spontaneous report from a contactable consumer (patient, self-reported). A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 11Apr2021 at 01:15 PM (age at vaccination: 56 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included history of ITP last time it was 5 years ago. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ep6955 and expiry date was not reported), via an unspecified route of administration, in Arm, on 21Mar2021 (age at vaccination: 56 years), as a single dose for COVID-19 immunization. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 31May2021, she had ITP platelet count of 32,000. The patient did not receive any treatment for the event. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Gingival swelling, Lymphadenopathy, Lymphoma, Mass excision
Clinical narrative: I'm not sure about anatomy and where or if there are lymph nodes in the head; lump behind her left ear which was measured to be 1 inch in length and a 1/2 inch in width and another lump on her head under her hair so it was difficult to visualize; had issues swallowing; her gums were swollen; Potentially a lymph node that got inflamed; This is a spontaneous report from a contactable Pharmacist via Medical Information Team.  A 29-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: ew0191 and expiration date: sep2021) via intramuscular route of administration at left deltoid on 05Jun2021 14:30 (at the age of 29-year-old) as dose 1 single for COVID-19 immunisation. Patient medical history and Concomitant medications were not reported. On an unspecified date patient experienced a lump behind her left ear which was measured to be 1 inch in length and a 1/2 inch in width and another lump on her head under her hair, so it was difficult to visualize. The caller reports that initially when the lump showed up it was not bothering her but now the patient sates that it was. initially after receiving the vaccine, had issues swallowing and her gums were swollen and Potentially a lymph node that got inflamed and patient was not sure about anatomy and where or if there are lymph nodes in the head. Outcome of the events was had issues swallowing and her gums were swollen was recovered on an unknown date and rest all the events were not recovered.   Information on Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of lymphoma cannot be excluded . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Blood pressure measurement, Depressed mood, Dizziness
Clinical narrative: patient BP (blood pressure) was 58/50; Felt dizzy, light headed and sick; Felt dizzy, light headed and sick; Heart palpitations/The patient heart races with the littlest workout; Tremors; Extreme anxiety; Muscle twitching; sadness; This is a spontaneous report from a contactable consumer (patient). A 38-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history was reported as none. The patient had no known allergies. Concomitant medications included Multi vitamin, Tumeric and Garlic pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 10:15 AM, the reporter stated that within a few minutes of receiving the shot patient felt dizzy, lightheaded and sick. Went to the hospital and the patient BP (blood pressure) was 58/50. Two days later started having heart palpitations and tremors, extreme anxiety. The patient has also developed constant muscle twitching in the past month. The patient heart races with the littlest workout so therefore the patient cannot do usual Peloton. The patient was very scared because patient was so healthy before and now the patient full of regret and sadness. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 58/50 on an unspecified date in Apr2021 (58/50). Therapeutic measures were taken as a result of events included IV, aspirin, imagining and blood tests. The events were assessed as serious (Hospitalization). The outcome of the event patient BP (blood pressure) was 58/50 was unknown and not recovered for other events.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Muscle twitching, Palpitations, Tremor
Clinical narrative: patient BP (blood pressure) was 58/50; Felt dizzy, light headed and sick; Felt dizzy, light headed and sick; Heart palpitations/The patient heart races with the littlest workout; Tremors; Extreme anxiety; Muscle twitching; sadness; This is a spontaneous report from a contactable consumer (patient). A 38-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (at the age of 38-years-old) as dose 1, single for covid-19 immunisation at Hospital. The patient medical history was reported as none. The patient had no known allergies. Concomitant medications included Multi vitamin, Tumeric and Garlic pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Apr2021 at 10:15 AM, the reporter stated that within a few minutes of receiving the shot patient felt dizzy, lightheaded and sick. Went to the hospital and the patient BP (blood pressure) was 58/50. Two days later started having heart palpitations and tremors, extreme anxiety. The patient has also developed constant muscle twitching in the past month. The patient heart races with the littlest workout so therefore the patient cannot do usual Peloton. The patient was very scared because patient was so healthy before and now the patient full of regret and sadness. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 58/50 on an unspecified date in Apr2021 (58/50). Therapeutic measures were taken as a result of events included IV, aspirin, imagining and blood tests. The events were assessed as serious (Hospitalization). The outcome of the event patient BP (blood pressure) was 58/50 was unknown and not recovered for other events.   Information on the lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: My face proceeded to become numb; The numbness worsened until a trip to the hospital was taken at approximately 12 pm that same day.; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EWOSIO, Expiration date: Not reported), at doctor's office/urgent care, via an unspecified route of administration in left arm on 17Jun2021 11:30 AM (at the age of 21-year-old) as single dose for Covid-19 immunization. The patient's medical history included autism, major depressive disorder, and headaches of unknown cause. Concomitant medications included citalopram. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 17Jun2021 12:00 PM, the patient experienced face proceeded to become numb and the numbness worsened until a trip to the hospital was taken at approximately 12 PM that same day. Patient had taken treatment of a steroid shot and a BENADRYL shot for reported events. Outcome of the events was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site hypoaesthesia
Clinical narrative: my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; my arm immediately began having to feeling of falling asleep/ It is from the injection site down to my fingers; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration, in left arm on 22May2021 at 13:00 (at the age of 42-years-old) as dose 2, single for covid-19 immunisation. Medical history included HBP, anxiety and shellfish allergy from an unknown date. Concomitant medications included buspirone; sertraline hydrochloride (ZOLOFT); amlodipine and metoprolol taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unspecified route of administration on 30Apr2021 (at the age of 42-years-old) in left arm for covid-19 immunization. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 22May2021 at 13:00 after receiving second dose, her arm immediately began to have feeling of falling asleep. On 20Jun2021, her arm continues to fall asleep. She can be swimming, doing nothing, sleeping, typing, resting or driving and it falls asleep. It was from the injection site down to her fingers. The case was assessed as serious (disability). No treatment was received for event. Outcome of events was not recovered.   Information on the lot/batch number has been requested. Further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Occupational exposure to sunlight, Photosensitivity reaction, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Over active immune system that led to photosensitivity.; Rash to face; Rash to scalp; Rash to arms.; Hair loss; All areas exposed to sun and heat; This is a spontaneous report from a contactable other hcp (Patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL1283, Expiration Date: not reported) via intramuscular, administered in right arm on 12Jan2021 14:30 as dose 2, single for COVID-19 immunization. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EH9899, Expiration Date: not reported) via intramuscular, administered in left arm on 22Dec2020 13:00 as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus, hypertension well managed, hyperlipidemia well managed and sleep apnea. The patient had no known allergies. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient experienced over active immune system that led to photosensitivity, rash to face, rash to scalp, rash to arms, hair loss, all areas exposed to sun and heat on 25Jan2021. The patient underwent lab tests and procedures which included red blood cell sedimentation rate increased: 59 on 25Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with Topical steroids, antihistamine Allegra, pepcid AC, singulair as the result of events. The outcome of the events were not recovered.; Sender's Comments: Based on the information given in narrative, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.