chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Papilloedema, Vitreous floaters
Clinical narrative: Optical nerve was swollen and Nerve was pushing inward; Had blindness in her left eye at 80 percent; A shadow at the top of her left eye; This spontaneous case was reported by a non-health professional and describes the occurrence of BLINDNESS (Had blindness in her left eye at 80 percent) and PAPILLOEDEMA (Optical nerve was swollen and Nerve was pushing inward) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 16-Apr-2021, the patient experienced VITREOUS FLOATERS (A shadow at the top of her left eye). On 21-Apr-2021, the patient experienced BLINDNESS (Had blindness in her left eye at 80 percent) (seriousness criterion medically significant). On 10-May-2021, the patient experienced PAPILLOEDEMA (Optical nerve was swollen and Nerve was pushing inward) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Had blindness in her left eye at 80 percent), PAPILLOEDEMA (Optical nerve was swollen and Nerve was pushing inward) and VITREOUS FLOATERS (A shadow at the top of her left eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient's husband stated "two days after his wife received the Moderna vaccine she had noticed a shadow at the top of her left eye. Patient stated a week later she had blindness in her left eye at 80 percent. His wife had seen an eye specialist and was told that her optical nerve was swollen and the nerve was pushing inward which was causing the snowy vision. Patient stated his wife cholesterol was 245. Patient's husband  stated his wife had blood work (results not provided) and 2 magnetic resonance imaging tests done (results not provided), on 10-May-2021.  She was seen at institute for the events.   Treatment medications was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient demographics were added and event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information has been provided at this time. Further information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Body temperature, Dizziness, Gait inability
Clinical narrative: Diagnosed with sepsis; Diagnosed with acute arthritic response; Felt feverish/fever of 103.8; Unable to walk; Joints were swelling; Felt dizzy; Sore in the knees and joints; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response) and PYREXIA (Felt feverish/fever of 103.8) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Felt feverish/fever of 103.8) (seriousness criterion hospitalization), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints). On 30-Apr-2021, the patient experienced GAIT INABILITY (Unable to walk). On 03-May-2021, the patient experienced SEPSIS (Diagnosed with sepsis) (seriousness criteria hospitalization and medically significant) and ARTHRITIS (Diagnosed with acute arthritic response) (seriousness criterion hospitalization). The patient was hospitalized on 03-May-2021 due to ARTHRITIS and SEPSIS, and then for 3 days due to PYREXIA. At the time of the report, SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response), PYREXIA (Felt feverish/fever of 103.8), GAIT INABILITY (Unable to walk), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.8 (High) high.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided by the reporter. Patient received antibiotics (unspecified) in the hospital for treatment of events.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Pyrexia, Sepsis
Clinical narrative: Diagnosed with sepsis; Diagnosed with acute arthritic response; Felt feverish/fever of 103.8; Unable to walk; Joints were swelling; Felt dizzy; Sore in the knees and joints; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response) and PYREXIA (Felt feverish/fever of 103.8) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Felt feverish/fever of 103.8) (seriousness criterion hospitalization), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints). On 30-Apr-2021, the patient experienced GAIT INABILITY (Unable to walk). On 03-May-2021, the patient experienced SEPSIS (Diagnosed with sepsis) (seriousness criteria hospitalization and medically significant) and ARTHRITIS (Diagnosed with acute arthritic response) (seriousness criterion hospitalization). The patient was hospitalized on 03-May-2021 due to ARTHRITIS and SEPSIS, and then for 3 days due to PYREXIA. At the time of the report, SEPSIS (Diagnosed with sepsis), ARTHRITIS (Diagnosed with acute arthritic response), PYREXIA (Felt feverish/fever of 103.8), GAIT INABILITY (Unable to walk), JOINT SWELLING (Joints were swelling), DIZZINESS (Felt dizzy) and ARTHRALGIA (Sore in the knees and joints) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103.8 (High) high.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant medications were not provided by the reporter. Patient received antibiotics (unspecified) in the hospital for treatment of events.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information has been provide at this time. Further information has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Loss of consciousness
Clinical narrative: Fall down completely to the floor; Felt extremely dizzy; Bad stomachache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fall down completely to the floor) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), HYDROCODONE, SIMVASTATINE and CYCLOBENZAPRINE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fall down completely to the floor) (seriousness criterion medically significant), DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache). On 29-Apr-2021, LOSS OF CONSCIOUSNESS (Fall down completely to the floor) had resolved. On 05-May-2021, DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment for the events included antacid.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-128874 (E2B Linked Report). This case was linked to MOD-2021-128772 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-128874:Husband 2nd dose
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pyrexia, Thrombosis, Ultrasound scan
Clinical narrative: Spontaneous blood clots; very swollwn leg; Fever; Chills; leg being lightly swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Spontaneous blood clots) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT), EMPAGLIFLOZIN (JARDIANCE), LEVOTHYROXINE, LISINOPRIL, METFORMIN, PRAVASTATIN, METOPROLOL, ARIPIPRAZOLE (ABILIFY), VENLAFAXINE HYDROCHLORIDE (EFFEXOR), FENTANYL, APIXABAN (ELIQUIS) and TESTOSTERONE for an unknown indication, CEFIXIME (FLEXERIL [CEFIXIME]).   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PERIPHERAL SWELLING (leg being lightly swollen), PYREXIA (Fever) and CHILLS (Chills). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (very swollwn leg). On an unknown date, the patient experienced THROMBOSIS (Spontaneous blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Spontaneous blood clots), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown and PERIPHERAL SWELLING (leg being lightly swollen) and PERIPHERAL SWELLING (very swollwn leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: blood clots blood clots.         On 25-APR-2021, patient experienced a very swollen leg and was scheduled an ultrasound which reveled blood clots on an unspecified date in 2021. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. For the event Thrombosis concomitant medication interactions are a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. For the event Thrombosis concomitant medication interactions are a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Faint for 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint for 15 minutes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included PROPRANOLOL from 26-Mar-2021 to an unknown date for Blood pressure, ATORVASTATIN from 17-Apr-2021 to an unknown date for Cholesterol, AMITRIPTYLINE from 03-Aug-2020 to an unknown date for Depression.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced SYNCOPE (Faint for 15 minutes) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint for 15 minutes) outcome was recovered. Action taken  in response to the events was not applicable as she has taken 2 doses.   This case was linked to MOD-2021-056362 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Blacked out; Fainted; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) and SYNCOPE (Fainted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainted) (seriousness criteria hospitalization and medically significant). On 01-Jan-2021, LOSS OF CONSCIOUSNESS (Blacked out) and SYNCOPE (Fainted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events have been provided at this time. No further information is expected at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events have been provided at this time. No further information is expected at this time
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture, Incomplete course of vaccination, Lower limb fracture, Neoplasm malignant
Clinical narrative: Cancer problems; Broken leg; Broken ankle; has not been able to get the second shot; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Cancer problems) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer problems) (seriousness criteria hospitalization and medically significant), LOWER LIMB FRACTURE (Broken leg) (seriousness criterion hospitalization), ANKLE FRACTURE (Broken ankle) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has not been able to get the second shot). At the time of the report, NEOPLASM MALIGNANT (Cancer problems), LOWER LIMB FRACTURE (Broken leg) and ANKLE FRACTURE (Broken ankle) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has not been able to get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated he had a dilemma with the coronavirus vaccination shot.  He got his first vaccination shot on 13-Jan-2021.  He knew he had supposed to get the second one 30-40 days after but he had had medical problems. He had broken leg and ankle and cancer problems that he said were unrelated and has been in and out of the hospital.  He had not been able to get the second shot. He wanted to know if he should start over with the first shot. Where referred to his HCP, he said his doctor just shrugged and did not give him an answer about what he should do.; Sender's Comments: Based on reporter's causality and lack of information regarding the events, the events Neoplasm malignant, Lower limb fracture and Ankle fracture are assessed as unlikely related to mRNA-1273. Company causality for Incomplete course of vaccination was assessed as not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Product dose omission issue
Clinical narrative: Heart failure; was scheduled for her second dose, but was unable to get it because she was hospitalized; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart failure) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder (heart condition) and Blood pressure high.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CARDIAC FAILURE (Heart failure) (seriousness criteria hospitalization and medically significant). On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was scheduled for her second dose, but was unable to get it because she was hospitalized). The patient was hospitalized from 09-May-2021 to 13-May-2021 due to CARDIAC FAILURE. On 11-May-2021, PRODUCT DOSE OMISSION ISSUE (was scheduled for her second dose, but was unable to get it because she was hospitalized) had resolved. On 13-May-2021, CARDIAC FAILURE (Heart failure) outcome was unknown.            The patient's concomitant medications included unspecified high blood pressure pills and heart pills. Treatment information was not provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died 2 hours after getting the vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Patient died 2 hours after getting the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant products were reported. The reporter was worried about the administration of the vaccine and wanted to know if there was a way for someone to help their community. Reporter had contacted everyone in Public health department of the rural hometown. With the amount of adverse reactions with vaccine reporter was concerned that the vaccine was not being stored properly or not been given properly and further reported that one person died and they were not reporting it because they did not trust the government. A patient died two hours after getting the Moderna vaccine.  No treatment information provided.  This is a case of sudden death in a female patient who died 2 hours after receiving a dose of vaccine. Very limited information regarding this event has been provided at this time.; Sender's Comments: This is a case of sudden death in a female patient who died 2 hours after receiving a dose of vaccine. Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: patient was administered 0.5ml dose of the Pfizer vaccine by accident, more than the recommended dose of the vaccine; arm soreness; This is a spontaneous report from a contactable nurse who reported similar events for 3 patients. This is the 1st of 3 reports.  A 52-year-old patient of unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at 0.5 mL, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was administered 0.5ml dose of BNT162B2 by accident, more than the recommended dose of the vaccine, on an unspecified date, as they thought they were administering the Moderna vaccine. Upon follow up on 07Jan2021, it was reported that a nurse in the vaccination clinic inadvertently administered 0.5 ml of the Pfizer vaccine to 3 patients. The nurse reported that the patient was fine, only experienced a little arm soreness after receiving the vaccine. The outcome of the event was unknown.  Follow up (07Jan2021 and 08Jan2021): New information received from a contactable nurse includes: patient information (patient's age added) and course information.  Information about Lot/Batch number has been requested.  Follow-Up (11Feb2021): Follow-up attempts are completed. No further information is expected.  Follow-up (19Feb2020): New information from a contactable nurse includes new event (little arm soreness).  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010560 same reporter, event and product, different patient;US-PFIZER INC-2021010559 same reporter, event and product, different patient
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: patient was administered 0.5 ml dose of BNT162B2 by accident, more than the recommended dose of the; arm soreness; This is a spontaneous report received via Medical information team from a contactable nurse who reported similar events for 3 patients. This is the second of 3 reports. A 42 year old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date, at 0.5 ml single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was administered 0.5 ml dose of BNT162B2 by accident, more than the recommended dose of the vaccine, as they thought they were administering the Moderna vaccine. Upon follow up on 07Jan2021, it was reported that a nurse in the vaccination clinic inadvertently administered 0.5 ml of the Pfizer vaccine to 3 patients. The nurse stated that the patient was fine, only experienced a little arm soreness after receiving the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow up (07Jan2021 and 08Jan2021): New information received from a contactable nurse includes: patient information (patient's age added) and course information.  Follow-Up (11Feb2021): Follow-up attempts are completed. No further information is expected.  Follow-up (19Feb2021): New information from a contactable nurse includes new non serious event (arm soreness).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010188 same reporter, event, product, different patient
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: patient was administered 0.5 ml dose of BNT162B2 by accident, more than the recommended dose of the vaccine; arm soreness; This is a spontaneous report via Medical information team from a contactable nurse who reported similar events for 3 patients. This is the 3rd of 3 reports. A 41 year old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at 0.5 ml single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered 0.5 ml dose of BNT162B2 by accident, more than the recommended dose of the vaccine, as they thought they were administering the Moderna vaccine. Upon follow up on 07Jan2021, it was reported that a nurse in the vaccination clinic inadvertently administered 0.5 ml of the Pfizer vaccine to 3 patients. The nurse stated the patient was fine, only experienced a little arm soreness after receiving the vaccine. The outcome of the event was unknown.     Information on the lot/batch number has been requested.  Follow-up (07Jan2021 and 08Jan2021): New information received from a contactable nurse includes: patient information (patient's age added) and course information.  Information on the lot/batch number has been requested.  Follow-Up (11Feb2021): Follow-up attempts are completed. No further information is expected.  Follow up (19Feb2021): New information from a contactable nurse includes new non serious event (arm soreness).   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010188 same reporter, event, product, different patient
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This is a spontaneous report received from a contactable consumer. This 75 year old female consumer (patient) reported for a herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm Left on 13Jan2021 14:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included iodine allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced lightheadedness on 02Feb2021 09:00 . The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Neck mass, Tenderness
Clinical narrative: Tender hard lump on neck under collarbone won't go away
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Cough, Dyspnoea, Echocardiogram
Clinical narrative: Approximately 3 days after shot I started having shortness of breath. This progressed into coughing fits while laying down and feeling a tightness in chest. And irregular heat beat.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Exercise electrocardiogram, Heart rate irregular
Clinical narrative: Approximately 3 days after shot I started having shortness of breath. This progressed into coughing fits while laying down and feeling a tightness in chest. And irregular heat beat.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: New and worsened muscle and joint pain. Treatment with Naprosyn sodium.  It is not improving
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: After my first shot my arm was sore but fine after a day. About a week later I noticed if I used the arm muscle it would burn at the injection site. Weeks later and I?m still feeling the burn.  Sometimes it burns in a larger area.  I chose my right arm for the second shot and it?s already less sore than my left.  The first shot was given like a punch in the arm. Quite painful. Maybe that?s what caused the reaction?
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: DAILY migraines - excedrin sometimes helps if I take it quickly enough. I used to get maybe 1 migraine a month and have now had them every single day since my first dose of Moderna. Worst migraine being 5/16/2021 the day after my second dose. Most excruciatingly painful migraine of my life.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate irregular
Clinical narrative: Irregular heart beat and my heart skips at interval.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable physician (the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The caller stated last Thursday she received the vaccine and only had a sore arm but she was worried because she did not check her temperature prior to the vaccine. She stated she did not have symptoms but asked if she should have checked it.  Information about lot/batch has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: chills; temperature and it was 101.4°F; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported) dose 1 via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old), as SINGLE for Covid 19 Immunisation. She stated that she was fine all day yesterday and this morning on 28Jan2021, at 10:00 am, she had experienced chills and stated that they went away. She further stated that she recently checked her temperature and it was 101.4 degree fahrenheit. The patient would like to know whether her symptoms were normal and how long will her symptoms would last. The patient underwent lab tests and procedures which included body temperature 101.4 degree fahrenheit in Jan2021. The outcome of the event chills was resolved and outcome for pyrexia was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dysgeusia, Dyspnoea, Headache, Lip swelling
Clinical narrative: "reacting" to the first dose of the COVID-19 vaccine/ had an "assessment by an Allergist"; Swollen tongue; swollen upper lip; Sore throat; Headache; Taste metallic; Breathing moderately compromised; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number was not reported, Batch/Lot Number was EL1283), via an unspecified route of administration, administered in Arm Left on 22Jan2021 14:00 as single dose for an COVID-19 immunization. Patient Age at Time of Vaccination was 68 years. No prior vaccination within 4 weeks other than Pfizer vaccine. The patient medical history and concomitant was not reported. Reporter stated that she did have an adverse event after receiving the Pfizer vaccine last Friday. Patient stated that twelve hours later (after vaccination) On 23Jan2021 she awoke in the night at 02:00AM with a swollen tongue and swollen upper lip, and her breathing moderately compromised. States she has been to an allergic who recommended she not take the second shot. She wants to take the second shot and that is why she is called today, to ask if she could take it. Adds a headache was what actually woke her up at 02:00AM in the morning and she also noticed a metallic taste in her mouth followed by a sore throat that lasted several days. She is scheduled for the second dose On 09Feb2021 at 14:30 the patient experienced "reacting" to the first dose of the covid-19 vaccine/ had an "assessment by an allergist on an unspecified date with outcome of unknown. The outcome of the events swollen tongue, swollen upper lip, headache and breathing moderately compromised was recovered on 23Jan2021, Sore throat recovered on 27Jan2021, taste metallic was not recovered.   Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information was added.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: "reacting" to the first dose of the COVID-19 vaccine/ had an "assessment by an Allergist"; Swollen tongue; swollen upper lip; Sore throat; Headache; Taste metallic; Breathing moderately compromised; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number was not reported, Batch/Lot Number was EL1283), via an unspecified route of administration, administered in Arm Left on 22Jan2021 14:00 as single dose for an COVID-19 immunization. Patient Age at Time of Vaccination was 68 years. No prior vaccination within 4 weeks other than Pfizer vaccine. The patient medical history and concomitant was not reported. Reporter stated that she did have an adverse event after receiving the Pfizer vaccine last Friday. Patient stated that twelve hours later (after vaccination) On 23Jan2021 she awoke in the night at 02:00AM with a swollen tongue and swollen upper lip, and her breathing moderately compromised. States she has been to an allergic who recommended she not take the second shot. She wants to take the second shot and that is why she is called today, to ask if she could take it. Adds a headache was what actually woke her up at 02:00AM in the morning and she also noticed a metallic taste in her mouth followed by a sore throat that lasted several days. She is scheduled for the second dose On 09Feb2021 at 14:30 the patient experienced "reacting" to the first dose of the covid-19 vaccine/ had an "assessment by an allergist on an unspecified date with outcome of unknown. The outcome of the events swollen tongue, swollen upper lip, headache and breathing moderately compromised was recovered on 23Jan2021, Sore throat recovered on 27Jan2021, taste metallic was not recovered.   Follow-up (28Jan2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported information was added.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Gait disturbance, Hypertension
Clinical narrative: Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; high blood pressure; This is a spontaneous report from a non-contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration, administered in left arm on 20Jan2021 at 15:30 (at the age of 76-years-old) as an unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks prior vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 07:00 (next day after vaccination), patient experienced slight dizziness when tying shoes getting out of bed for four days though alpine skiing each of those days then fifth day dizzy almost staggering all day and high blood pressure. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Rhinorrhoea, Vaccination site pain
Clinical narrative: Throbbing and painful to move/lift; After first dose:  extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use.  Throbbing and painful to move/lift.  I also had a runny nose the day after first; After first dose:  extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use.  Throbbing and painful to move/lift.  I also had a runny nose the day after first; This is a spontaneous report from a non-contactable health care professional (Patient, self-reported). A 50-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EH9899, Expiration date: Not reported) via an unspecified route of administration, administered in left arm on 18Dec2020 18:15 as 1st Dose single for covid-19 immunization. Medical history included hypertension, blood cholesterol, latex sensitivity and GI upset from eggs and soy. Concomitant medications included atorvastatin; fexofenadine hydrochloride (ALLEGRA); hydrochlorothiazide/losartan potassium (LOSARTAN HCTZ). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Patient received bnt162b2 (Batch/Lot number= EL3249), via an unspecified route of administration, administered in left arm on 08Jan2021, 06:15 PM, 2nd DOSE, SINGLE. On an unknown date, after first dose patient had extremely sore injection site arm (deltoid) that woke me the first 2 nights even with Tylenol use. Throbbing and painful to move/lift. I also had a runny nose the day after first dose. Symptoms resolved by 3rd day after injection. Treatment received with Tylenol, Ibuprofen and Benadryl. Outcome of the events was recovered.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021090292 similar report from same reporter
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dizziness, Ear pain
Clinical narrative: dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Insomnia, Lymphadenopathy
Clinical narrative: dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Off label use, Pain, Paraesthesia
Clinical narrative: dose 1: 05Jan2021; dose 2: 22Jan2021; dose 1: 05Jan2021; dose 2: 22Jan2021; ear ache; Cough; congestion; loss of appetite; Headaches; fatigue; right axillary lymph node swollen; Dizziness; Room spinning; nausea; body and face tingling; chills; body aches; insomnia; This is a spontaneous report from a contactable nurse reporting for herself. This 42-year-old female nurse (Patient) reported that: A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:00 AM (Batch/Lot Number: EL3249) as SINGLE DOSE for COVID-19 immunization. Patient also received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 05Jan2021 09:30 AM, (Batch/Lot Number: EK9231) as SINGLE DOSE for COVID-19 immunization (time interval between two doses: 18 days). Medical history included drug hypersensitivity, to Penicillin, tetracycline. Concomitant medication included cetirizine hydrochloride (ZYRTEC) 1x/day and Multivitamins. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient did not test COVID post vaccination. On 22Jan2021 10:00 PM, the patient experienced dizziness, room spinning, nausea, body and face tingling, chills, body aches and insomnia. Also, it was reported that, the patient had fatigue, right axillary lymph node swollen on 23Jan2021, on 24Jan2021: dizziness had nausea. On 26Jan2021: Dizziness, nausea, loss of appetite, tingling face and body and headache. On 27Jan2021: Dizziness, nausea, tingling face and body, cough, congestion and on 28Jan2021: Cough, congestion, earache. On 29Jan2021, the patient presented with dizziness, tingling face and body, cough congestion, and headache. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for adverse events. The patient was recovering from all the event at time of reporting.   Follow-up attempts are completed. No further information is expected.