chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not received 1st and 2nd Moderna doses but received a Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not received 1st and 2nd Moderna doses but received a Moderna booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not received 1st and 2nd Moderna doses but received a Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  There were no vaccine records reported on the state website for the patient and the pharmacy had no records of ever giving the vaccine to the patient and the patient received a booster. Now months later the manager indicates they thought the patient had 1st and 2nd Moderna dose but in reality, they never did so they are requesting to give 1st and 2nd Moderna doses.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: Few things different from before I got my shot; stuff arm; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Few things different from before I got my shot) and MUSCULOSKELETAL STIFFNESS (stuff arm) 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 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Few things different from before I got my shot) and MUSCULOSKELETAL STIFFNESS (stuff arm). At the time of the report, FEELING ABNORMAL (Few things different from before I got my shot) and MUSCULOSKELETAL STIFFNESS (stuff arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported. Patient was feeling ok after vaccination.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had my Moderna booster 70 days after my second dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose) in a 57-year-old patient of an unknown 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had my Moderna booster 70 days after my second dose) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  patient was in good health.  No Treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness still after 3 days on my arm; a bit of swell; inappropriate schedule of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm), VACCINATION SITE SWELLING (a bit of swell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm), VACCINATION SITE SWELLING (a bit of swell) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (redness still after 3 days on my arm) and VACCINATION SITE SWELLING (a bit of swell) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.The patient had 3rd shot on Friday (unspecified) Moderna. The patient two previous doses were Pfizer.   Reporter did not allow further contact
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed her 2nd dose which was scheduled in Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Has a thyroid problem and has medication) and AFib.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose which was scheduled in Nov2021) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The reporter stated that the patient has a thyroid problem for which she has medication, and no other concomitant medications were reported.  The patient received the first dose of the Moderna Covid-19 on 28-Oct-2021 at a local pharmacy but missed her second dose which was scheduled in Nov-2021 because she was kind of worried about that.   Treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Myalgia
Clinical narrative: felt weird,like everything in his body was shutting down/ booster shot really screwed him up; a lump in his left armpit; felt really sore/body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up) and MYALGIA (felt really sore/body aches). 17-Nov-2021, the patient experienced AXILLARY MASS (a lump in his left armpit). At the time of the report, FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) outcome was unknown.        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 reported.   This case was linked to MOD-2022-447062 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Feeling abnormal, Myalgia
Clinical narrative: Felt weird, like everything in his body was shutting down/ really screwed me up; I had a lump in my left armpit; Experienced body aches and felt really sore; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Felt weird, like everything in his body was shutting down/ really screwed me up), AXILLARY MASS (I had a lump in my left armpit) and MYALGIA (Experienced body aches and felt really sore) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced FEELING ABNORMAL (Felt weird, like everything in his body was shutting down/ really screwed me up) and MYALGIA (Experienced body aches and felt really sore). 03-Feb-2021, the patient experienced AXILLARY MASS (I had a lump in my left armpit). At the time of the report, FEELING ABNORMAL (Felt weird, like everything in his body was shutting down/ really screwed me up), AXILLARY MASS (I had a lump in my left armpit) and MYALGIA (Experienced body aches and felt really sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he was not on any concomitant medications. No treatment information was provided.   This case was linked to MOD-2022-447033 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Her daughter has redness at injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose) 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 VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose). At the time of the report, VACCINATION SITE ERYTHEMA (Her daughter has redness at injection site after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood triglycerides, Chest pain, High density lipoprotein, Low density lipoprotein
Clinical narrative: bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arterial calcification (Patient do have some calcification in my arteries, but, not enough to treat.), Non-smoker and Cholesterol (ratio 2.1). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.). At the time of the report, CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, Mammogram: normal (normal) no suspicious calcifications were identified. On an unknown date, Blood cholesterol: 148 148. On an unknown date, Blood triglycerides: 57 57. On an unknown date, High density lipoprotein: 69 69. On an unknown date, Low density lipoprotein: 68 68. On an unknown date, Non-high-density lipoprotein cholesterol: 79 79. On an unknown date, Very low density lipoprotein: 11 11.         Patient experienced the event after the second dose, while sleeping that lasted 15 seconds and didn't came back when turned over.  Patient received booster dose of Pfizer on 11 Nov 2021 (batch no FJ1611) and on the second day experienced serious pain. First, patient said that it was in her heart, but then she retracted and said it was in the arteries of the breast. At the time of this report, patient felt that the lining around the heart was inflamed.  Patient doesn't have a history of COVID-19 infection and doesn't have a history of myocarditis or pericarditis.  Patient's regular medication included cholesterol pill and provided the cholesterol levels.  Patient don't drink and eat healthy food.  No treatment medications were taken by the patient after Moderna vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Non-high-density lipoprotein cholesterol, Very low density lipoprotein
Clinical narrative: bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arterial calcification (Patient do have some calcification in my arteries, but, not enough to treat.), Non-smoker and Cholesterol (ratio 2.1). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.). At the time of the report, CHEST PAIN (bad pain in my heart, t that lasted 15 seconds the second week while I was sleeping  and turned over.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, Mammogram: normal (normal) no suspicious calcifications were identified. On an unknown date, Blood cholesterol: 148 148. On an unknown date, Blood triglycerides: 57 57. On an unknown date, High density lipoprotein: 69 69. On an unknown date, Low density lipoprotein: 68 68. On an unknown date, Non-high-density lipoprotein cholesterol: 79 79. On an unknown date, Very low density lipoprotein: 11 11.         Patient experienced the event after the second dose, while sleeping that lasted 15 seconds and didn't came back when turned over.  Patient received booster dose of Pfizer on 11 Nov 2021 (batch no FJ1611) and on the second day experienced serious pain. First, patient said that it was in her heart, but then she retracted and said it was in the arteries of the breast. At the time of this report, patient felt that the lining around the heart was inflamed.  Patient doesn't have a history of COVID-19 infection and doesn't have a history of myocarditis or pericarditis.  Patient's regular medication included cholesterol pill and provided the cholesterol levels.  Patient don't drink and eat healthy food.  No treatment medications were taken by the patient after Moderna vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Mild flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Mild flu) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AC1A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA (Mild flu). On 20-Mar-2021, INFLUENZA (Mild flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was not on any concomitant medication. No treatment medication was reported. It was reported that the patient drank a lot of water.   This case was linked to MOD-2022-447163, MOD-2022-447164 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tenderness
Clinical narrative: it hurt like hell; His arm was a little tender; tired / fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it hurt like hell), TENDERNESS (His arm was a little tender) and FATIGUE (tired / fatigued) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PAIN (it hurt like hell), TENDERNESS (His arm was a little tender) and FATIGUE (tired / fatigued). On 14-May-2021, PAIN (it hurt like hell), TENDERNESS (His arm was a little tender) and FATIGUE (tired / fatigued) had resolved.            No concomitant medication were reported.  The patient did not took any medications or treatments, but massaged the injection area.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Influenza like illness, Pain in jaw
Clinical narrative: very mild flu like symptoms; very mild chest pressure; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (very mild flu like symptoms), CHEST DISCOMFORT (very mild chest pressure) and PAIN IN JAW (Jaw pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (very mild flu like symptoms), CHEST DISCOMFORT (very mild chest pressure) and PAIN IN JAW (Jaw pain). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (very mild flu like symptoms), CHEST DISCOMFORT (very mild chest pressure) and PAIN IN JAW (Jaw pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter and does not consulted the HCP and waited for the symptoms to go away and drank lots of water.  Patient has also said that the experienced symptoms were resolved very fast after 24 hours and not as long as with the first dose.   This case was linked to MOD-2022-447122, MOD-2022-447164 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Gait disturbance, Influenza like illness, Thirst
Clinical narrative: woke up extremely thirsty, more thirsty than normal; she almost fell; she couldn´t even walk, she thought she was going to fall, she couldn´t get her; dizzy, so dizzy; a little flu like symptoms but not as much; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much), THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much). On an unknown date, the patient experienced THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy). At the time of the report, INFLUENZA LIKE ILLNESS (a little flu like symptoms but not as much), THIRST (woke up extremely thirsty, more thirsty than normal), FALL (she almost fell), GAIT DISTURBANCE (she couldn´t even walk, she thought she was going to fall, she couldn´t get her) and DIZZINESS (dizzy, so dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. Patient had event about 12 hours after receiving the dose.   This case was linked to MOD-2022-447163, MOD-2022-447122 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction from Moderna Booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.  Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for Prophylactic vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction from Moderna Booster). At the time of the report, VACCINATION COMPLICATION (Reaction from Moderna Booster) outcome was unknown. No concomitant medications were provided by the reporter. No treatment was provided by the reporter. Patient stated that they gave Moderna booster and on the paperwork, it said JNJ COVID booster.  The suspect product quality complaint has been confirmed to be voided (and did not meet Product Quality Complaint criteria) based on the RA evaluations.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: booster side effects; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (booster side effects) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (booster side effects). At the time of the report, VACCINATION COMPLICATION (booster side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported   No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: On my vaccination there is an expiration date that has passed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On my vaccination there is an expiration date that has passed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No Treatment medications reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How many people have side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (How many people have side effects) 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 VACCINATION COMPLICATION (How many people have side effects). At the time of the report, VACCINATION COMPLICATION (How many people have side effects) outcome was unknown.        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 treatment medication was reported. No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potential Vaccine given >12 hour post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Potential Vaccine given >12 hour post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that one of their nurses gave a patient the first dose of the Moderna vaccine from a vial that was not dated appropriately. Initially it was said the vial was at room temperature for 6 hours and then given. And then the nurse indicated that she thought it might have been longer than 12 hours.  No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: don't feel very well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel very well) 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 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (don't feel very well). At the time of the report, MALAISE (don't feel very well) had not resolved.            No concomitant medications were provided.  No treatment medications were provided.  Symptoms onset date will be in JAN 2022.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: noticed significant improvement in my vision; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Retinitis pigmentosa (x-link), Peripheral vision defective and Night blindness.    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 THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (noticed significant improvement in my vision) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient have noticed a lot of changes after vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and MYALGIA (body ache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body ache). At the time of the report, PYREXIA (fever) and MYALGIA (body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: got Moderna also has ringing in the ears now; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (got Moderna also has ringing in the ears now) 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 TINNITUS (got Moderna also has ringing in the ears now). At the time of the report, TINNITUS (got Moderna also has ringing in the ears now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-446784 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Migraine, Vaccination site pain
Clinical narrative: arm at the injection site still to this day feels like it is continuously being stabbed it hurts so bad; constant migraine that comes and goes every day for hours; Feeling extremely exhausted; diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Aug2021 08:00 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin; Amoxicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "arm at the injection site still to this day feels like it is continuously being stabbed it hurts so bad"; MIGRAINE (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "constant migraine that comes and goes every day for hours"; FATIGUE (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "Feeling extremely exhausted"; DIARRHOEA (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "diarrhea". Therapeutic measures were not taken as a result of vaccination site pain, migraine, fatigue, diarrhoea. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. The first three days after the shot patient had a constant severe migraine that would not go away. The reported events did not result in any seriousness criteria.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling hot, Illness, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Having like weird side effects kind of my nose got runny; I have been sick; I got too hot; I am right on the bed; Having red eyes; Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night; Throat itch like it hurts; I got too hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 (Lot number: EW0173) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: I am Asthmatic like some times I can't Breath.; "Allergies to seafood" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that; "Allergies to packaged food" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Having like weird side effects kind of my nose got runny"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have been sick; I got too hot; I am right on the bed"; OCULAR HYPERAEMIA (non-serious) with onset 2021, outcome "unknown", described as "Having red eyes"; EYE PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night"; THROAT IRRITATION (non-serious) with onset 2021, outcome "unknown", described as "Throat itch like it hurts"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "I got too hot". Therapeutic measures were taken as a result of ocular hyperaemia, eye pruritus.  No follow-up attempts are possible. No further information is expected.  Additional Information: Reason for no lot number: of Covid-19 Vaccine: Other: The patient stated, On the paper that they gave me, the person who gave it to me as PS12ER and the bottom of it LOT#EW0173. When probed for vaccine expiration date,patient stated, "There was no expiration date. When probed for patient  weight, patient stated, "patient don't know really. When probed event start date, patient stated, She took the shot and after a couple of days she started having the side effect. Patient  stated, She got too hot.When probed if still having the problem (events),patient  stated, Yes, I just took my cousin (not clarified) told me to take Azelastine eye drops. When probed for event outcome, patient stated, She don't right now and was hot under the same. The patient was  right on the bed,was right now having something like this. Right now I don't know much. The patient was  sick right now." (Event outcome further not clarified. Hence, not captured in the tab).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Having like weird side effects kind of my nose got runny; I have been sick; I got too hot; I am right on the bed; Having red eyes; Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night; Throat itch like it hurts; I got too hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 (Lot number: EW0173) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: I am Asthmatic like some times I can't Breath.; "Allergies to seafood" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that; "Allergies to packaged food" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Having like weird side effects kind of my nose got runny"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have been sick; I got too hot; I am right on the bed"; OCULAR HYPERAEMIA (non-serious) with onset 2021, outcome "unknown", described as "Having red eyes"; EYE PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night"; THROAT IRRITATION (non-serious) with onset 2021, outcome "unknown", described as "Throat itch like it hurts"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "I got too hot". Therapeutic measures were taken as a result of ocular hyperaemia, eye pruritus.  No follow-up attempts are possible. No further information is expected.  Additional Information: Reason for no lot number: of Covid-19 Vaccine: Other: The patient stated, On the paper that they gave me, the person who gave it to me as PS12ER and the bottom of it LOT#EW0173. When probed for vaccine expiration date,patient stated, "There was no expiration date. When probed for patient  weight, patient stated, "patient don't know really. When probed event start date, patient stated, She took the shot and after a couple of days she started having the side effect. Patient  stated, She got too hot.When probed if still having the problem (events),patient  stated, Yes, I just took my cousin (not clarified) told me to take Azelastine eye drops. When probed for event outcome, patient stated, She don't right now and was hot under the same. The patient was  right on the bed,was right now having something like this. Right now I don't know much. The patient was  sick right now." (Event outcome further not clarified. Hence, not captured in the tab).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113; I get shortness of breath and get out breath, when I start walk; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: EW0176) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bulging Disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEART RATE INCREASED (non-serious) with onset 31Jul2021, outcome "unknown", described as "It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "I get shortness of breath and get out breath, when I start walk"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". The events "it's like my heart was going to rip of my chest, so i get closed off down, it said my heart rate was 125/whenever i move around, walk in around my heart rate jumps up, it were 130,125,113", "i get shortness of breath and get out breath, when i start walk" and "headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.  Additional Information: Prior vaccination within 4 weeks was reported as none and they give D10 or something to make sure the patient didn't have any clot.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, X-ray
Clinical narrative: It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113; I get shortness of breath and get out breath, when I start walk; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: EW0176) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bulging Disease" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEART RATE INCREASED (non-serious) with onset 31Jul2021, outcome "unknown", described as "It's like my heart was going to rip of my chest, so I get closed off down, it said my heart rate was 125/Whenever I move around, walk in around my heart rate jumps up, it were 130,125,113"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "I get shortness of breath and get out breath, when I start walk"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache". The events "it's like my heart was going to rip of my chest, so i get closed off down, it said my heart rate was 125/whenever i move around, walk in around my heart rate jumps up, it were 130,125,113", "i get shortness of breath and get out breath, when i start walk" and "headache" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased.  Additional Information: Prior vaccination within 4 weeks was reported as none and they give D10 or something to make sure the patient didn't have any clot.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy, painful rash on arm that was vaccinated; Itchy, painful rash on arm that was vaccinated; Itchy, painful rash on arm that was vaccinated; Rash has clusters of raised, red bumps with puss that crusts over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 (Lot number: EW0185) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergies: gluten, reaction(s): "Allergies: Gluten allergy", notes: Allergies: Gluten allergy. Vaccination history included: Bnt162b2 (lot number: EW0185, dose number: 1, vaccine location: Left arm), administration date: 14Jul2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE RASH (non-serious) all with onset 12Aug2021, outcome "recovering" and all described as "Itchy, painful rash on arm that was vaccinated"; RASH ERYTHEMATOUS (non-serious) with onset 12Aug2021, outcome "recovering", described as "Rash has clusters of raised, red bumps with puss that crusts over". The events "itchy, painful rash on arm that was vaccinated", "itchy, painful rash on arm that was vaccinated", "itchy, painful rash on arm that was vaccinated" and "rash has clusters of raised, red bumps with puss that crusts over" were evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash, rash erythematous.  Additional Information: Patient did not test positive prior to and post vaccination. Had no other vaccine in four weeks. Adverse events were treated with Steroid cream and resulted in Doctor or other healthcare professional office/clinic visit.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: My eye is swollen, just my right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: FC3181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1, Anatomical site of vaccination: Left arm, Lot Number: FA7484), for Covid-19 Immunization. The following information was reported: EYE SWELLING (non-serious) with onset 15Aug2021, outcome "not recovered", described as "My eye is swollen, just my right eye". Therapeutic measures were not taken as a result of eye swelling.  Additional Information: Patient took low dose of Blood Pressure medication. The patient had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.