chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration and the vials did not undergo any temperature excursions.  No concomitant drug information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  No treatment drugs were reported.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.   No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant drugs were not reported. Treatment medications were not provided. It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration where the vials did not undergo any temperature excursion.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Palpitations, Pericarditis
Clinical narrative: Pericarditis; Chest constriction; Difficulty breathing; Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 02Sep2021 (Lot Number: EW0165) at the age of 33 years as single dose for covid-19 immunisation. Medical history included known allergies: penicillin. There were no concomitant medications. No COVID prior vaccination. No other vaccine in four weeks. Patient experienced chest constriction, heart palpitations, difficulty breathing, abnormal EKG ultimately diagnosed as pericarditis on 04Sep2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. Covid test type post vaccination: Nasal swab Post on 06Sep2021 was negative. Outcome of events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Pericarditis; Chest constriction; Difficulty breathing; Heart Palpitations; This is a spontaneous report from a contactable consumer (patient). A 33-years-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 02Sep2021 (Lot Number: EW0165) at the age of 33 years as single dose for covid-19 immunisation. Medical history included known allergies: penicillin. There were no concomitant medications. No COVID prior vaccination. No other vaccine in four weeks. Patient experienced chest constriction, heart palpitations, difficulty breathing, abnormal EKG ultimately diagnosed as pericarditis on 04Sep2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received. Covid test type post vaccination: Nasal swab Post on 06Sep2021 was negative. Outcome of events were recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: mild itching; This is a spontaneous report from a contactable pharmacist (patient). A 72-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Jan2021 10:00 (Lot Number: EL9261) at the age of 72 years as single dose for covid-19 immunisation. Medical history included high cholesterol, osteopenia, hypertension (HBP), macular degeneration, known allergies: sulfa antibiotics, IVP dye, latex, Macrobid. Concomitant medications included losartan; simvastatin; vitamin d; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION). Patient was not pregnant. No other vaccine in four weeks. Patient had no covid prior vaccination and did not test post vaccination. Patient experienced after first dose, mild itching in Feb2021. Ae resulted in doctor or other healthcare professional office/clinic visit. Treatment prednisone dosepak, steroid cream received. Outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: having covid; This is a spontaneous report from a contactable Other HCP. This Other HCP reported that a 74-year-old female patient received palbociclib (IBRANCE, formulation: Film-coated tablet, strength: 125 mg, Batch/Lot number was not reported), via an unspecified route of administration from 29Jul2019 to an unspecified date, at 125 mg for an unspecified indication and bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot number was not reported, age at the time of vaccination was not provided), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported having Covid from 21Aug to 15Sep (unspecified year). she did have an ER visit for a shot for Covid and would be having an MRI tomorrow. The action taken in response to the event for palbociclib was unknown and for bnt162b2 was not applicable. The outcome of the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest discomfort, Dizziness, Echocardiogram
Clinical narrative: Missed so far about 6 days work, can't move with out fast heartbreak; chest tightness continuous.; pain with deep breathing; fast heart beat; dizziness; shoulder pain left side; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Sep2021 15:00 (Batch/Lot Number: FF3389) at age of 25-years-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none, patient was healthy. There were no concomitant medications. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced chest tightness continuous on 27Sep2021 05:00 with outcome of recovering, pain with deep breathing on 27Sep2021 05:00 with outcome of recovering, fast heart beat on 2021 with outcome of recovering, dizziness on 2021 with outcome of recovering, shoulder pain left side on 2021 with outcome of recovering. Clinical course reported as follow: On 27Sep2021 5am woke up chest tightness, pain with deep breathing, last all week with fast heart beat and dizziness, shoulder pain left side, went to Dr primary on 04Oct2021 blood test, EKG then seen cardiologist on 06Oct2021 for exam, echocardiogram, holster monitor, noted by both physicians as vaccine related. Will not get second dose. Missed so far about 6 days work, can't move with out fast heartbreak, pain, chest tightness continuous. Treatment received on 04Oct2021 for the events. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Heart rate, Heart rate increased, Impaired work ability
Clinical narrative: Missed so far about 6 days work, can't move with out fast heartbreak; chest tightness continuous.; pain with deep breathing; fast heart beat; dizziness; shoulder pain left side; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Sep2021 15:00 (Batch/Lot Number: FF3389) at age of 25-years-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none, patient was healthy. There were no concomitant medications. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced chest tightness continuous on 27Sep2021 05:00 with outcome of recovering, pain with deep breathing on 27Sep2021 05:00 with outcome of recovering, fast heart beat on 2021 with outcome of recovering, dizziness on 2021 with outcome of recovering, shoulder pain left side on 2021 with outcome of recovering. Clinical course reported as follow: On 27Sep2021 5am woke up chest tightness, pain with deep breathing, last all week with fast heart beat and dizziness, shoulder pain left side, went to Dr primary on 04Oct2021 blood test, EKG then seen cardiologist on 06Oct2021 for exam, echocardiogram, holster monitor, noted by both physicians as vaccine related. Will not get second dose. Missed so far about 6 days work, can't move with out fast heartbreak, pain, chest tightness continuous. Treatment received on 04Oct2021 for the events. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: Missed so far about 6 days work, can't move with out fast heartbreak; chest tightness continuous.; pain with deep breathing; fast heart beat; dizziness; shoulder pain left side; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Sep2021 15:00 (Batch/Lot Number: FF3389) at age of 25-years-old as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none, patient was healthy. There were no concomitant medications. No known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced chest tightness continuous on 27Sep2021 05:00 with outcome of recovering, pain with deep breathing on 27Sep2021 05:00 with outcome of recovering, fast heart beat on 2021 with outcome of recovering, dizziness on 2021 with outcome of recovering, shoulder pain left side on 2021 with outcome of recovering. Clinical course reported as follow: On 27Sep2021 5am woke up chest tightness, pain with deep breathing, last all week with fast heart beat and dizziness, shoulder pain left side, went to Dr primary on 04Oct2021 blood test, EKG then seen cardiologist on 06Oct2021 for exam, echocardiogram, holster monitor, noted by both physicians as vaccine related. Will not get second dose. Missed so far about 6 days work, can't move with out fast heartbreak, pain, chest tightness continuous. Treatment received on 04Oct2021 for the events. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Constipation, Dyspepsia, Dyspnoea, Ear swelling
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gingival bleeding, Gingival pain, Gingival swelling, Headache
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hypoaesthesia, Muscle tightness, Nausea, Pain
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Postmenopausal haemorrhage, Rash, Swelling, Tremor
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Dyspnoea, Ear swelling, Fatigue, Gingival bleeding
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival pain, Gingival swelling, Headache, Heart rate irregular, Hyperchlorhydria
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nausea, Pain, Pharyngeal swelling, Postmenopausal haemorrhage
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin tightness, Somnolence, Swelling, Tremor
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Difficulty breathing for 1/2 hour; Body numb; Extreme shaking; Nausea; Then whole body aching; Tight all over; Skin rash; Very tired in afternoons and sleep necessary at that point; Swollen around ear, neck and throat; Swollen around ear, neck and throat; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Sore gums and swollen and bleeding gums; Constipation; Irregular heartbeat; Extreme acid stomach; Weakness; Vaginal bleeding (past menopause for 3 years); Ear swelling; Sharp headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 29Sep2021 13:00 (Batch/Lot number was not reported) at the age of 50 years as single dose for covid-19 immunisation. Medical history included known allergies: very sensitive to any medicine. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Patient had no covid prior vaccination, no covid tested post vaccination. Patient experienced sharp headache, difficulty breathing for 1/2 hour, body numb, extreme shaking, nausea, then whole body aching, tight all over, skin rash, very tired in afternoons and sleep necessary at that point, swollen around ear, neck and throat, sore gums and swollen and bleeding gums, vaginal bleeding (past menopause for 3 years), constipation, irregular heartbeat, extreme acid stomach, Symptoms started about 4 hours after injection and continued all night. Nausea, weakness, acid stomach, ear swelling, heartbeat, sore gums all still continue 5 days later. Adverse event start time was on 29Sep2021 05:00 PM. Case was reported as non-serious. Treatment was received acid pills massage for tightness, pain ointm. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date; developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients (uncle and aunty). This is the 2nd (aunty) of 2 reports. An elderly female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. Non-pregnant at time of vaccination. The patient medical history and concomitant medications were not reported. No Covid prior vaccination. No other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient received the Pfizer BioNTech vaccine booster (completing the series of 3) and developed symptoms on 25Sep2021 and became sero positive for COVID-19 on an unspecified date, thus qualifying as a lack of efficacy AE (adverse event). The events did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date. Therapeutic measures were taken as a result of the events included regeneron monoclonal antibodies. The outcome of the events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202101325477 same reporter/drug/event, different patient
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Dyspnoea, Memory impairment
Clinical narrative: Confusion; Tinnitus; Memory issues; Fever; chills; Hives; Night sweating; Restless legs; Achy joints; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: Wagg388 FC3181), first dose via an unspecified route of administration, administered in left arm on 10Sep2021 15:00 at the age of 45-year-old as single dose for covid-19 immunization. Medical history included Covid positive in December 2020, nothing chronic, some food allergies, corn, onions, peanut, bean from an unknown date and unknown if ongoing. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. The patient experienced confusion, tinnitus, memory issues, fever, chills, hives, night sweating, achy joints, shortness of breath all on 12Sep2021 01:30, restless legs on 12Sep2021. Confusion for a week, tinnitus got worse and hasn't subsided memory issues, ongoing fever & chills, hives during the night three times 1st week after dose. Night sweating off and on restless legs, still ongoing achy joints, still ongoing shortness of breath, still ongoing. He had scheduled a doctor's appointment to see if he could remedy some of these. The case was reported as serious per disability. The event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment for adverse events. No covid tested post vaccination. The patient underwent lab tests and procedures which included Covid-19: positive in Dec2020. The outcome of events was not resolved. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient hadn't been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Restless legs syndrome, SARS-CoV-2 test, Tinnitus
Clinical narrative: Confusion; Tinnitus; Memory issues; Fever; chills; Hives; Night sweating; Restless legs; Achy joints; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (Pfizer, Batch/Lot Number: Wagg388 FC3181), first dose via an unspecified route of administration, administered in left arm on 10Sep2021 15:00 at the age of 45-year-old as single dose for covid-19 immunization. Medical history included Covid positive in December 2020, nothing chronic, some food allergies, corn, onions, peanut, bean from an unknown date and unknown if ongoing. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks. The patient experienced confusion, tinnitus, memory issues, fever, chills, hives, night sweating, achy joints, shortness of breath all on 12Sep2021 01:30, restless legs on 12Sep2021. Confusion for a week, tinnitus got worse and hasn't subsided memory issues, ongoing fever & chills, hives during the night three times 1st week after dose. Night sweating off and on restless legs, still ongoing achy joints, still ongoing shortness of breath, still ongoing. He had scheduled a doctor's appointment to see if he could remedy some of these. The case was reported as serious per disability. The event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment for adverse events. No covid tested post vaccination. The patient underwent lab tests and procedures which included Covid-19: positive in Dec2020. The outcome of events was not resolved. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient hadn't been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.