chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Very little side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Very little side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very little side effects). At the time of the report, VACCINATION COMPLICATION (Very little side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 78-year-old female patient 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, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.            Concomitant product use details was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-016974 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, GABAPENTIN, AMITRIPTYLINE, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved.            Treatment information was unknown.   This case was linked to MOD-2021-256793 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering uncontrollably for 2 to 2 and half hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering uncontrollably for 2 to 2 and half hours) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, BIFIDOBACTERIUM LACTIS, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (FLORAJEN 3), DOCUSATE SODIUM (STOOL SOFTENER), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID (VITAMIIN C) for an unknown indication.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced CHILLS (Shivering uncontrollably for 2 to 2 and half hours). At the time of the report, CHILLS (Shivering uncontrollably for 2 to 2 and half hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up information  received and contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-030988 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Complication of device removal, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Was unable to remove cleo tubing from site and had to start a new one; temperature 100; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one), PYREXIA (temperature 100) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM injection for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included AMBRISENTAN, RIOCIGUAT (ADEMPAS) and RIVAROXABAN (XARELTO) for an unknown indication.   On 10-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (Subcutaneous) .012 continously. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one), PYREXIA (temperature 100) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature 100) and HEADACHE (headache) was resolving and COMPLICATION OF DEVICE REMOVAL (Was unable to remove cleo tubing from site and had to start a new one) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Body temperature: 100 (High) Body temperature 100 F.         No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pain in jaw
Clinical narrative: a severe pain in the right part of jaw; Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (a severe pain in the right part of jaw), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) 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, the patient experienced PAIN IN JAW (a severe pain in the right part of jaw), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN JAW (a severe pain in the right part of jaw) had not resolved and PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medication was provided.  No Treatment medication was provided.  Patient reports that pain in jaw reduced by drinking water and walking.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Translation Received on 21-July-2021 and contains dose information and added events
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in an 85-year-old female patient 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) (Intramuscular) 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 INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.            No concomitant medications were provided. Treatment information was not provided.  Patient stated that flu-like symptoms which she experienced post second dose was more worse than post the first dose. However, she was feeling fine now.   This case was linked to MOD-2021-020927 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Very little side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Very little side effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Drug allergy (Keppra).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ADVERSE EVENT (Very little side effect). At the time of the report, ADVERSE EVENT (Very little side effect) outcome was unknown.            Concomitant medication use was not provided. No Treatment information was provided.   This case was linked to MOD-2021-033355 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia and fatigue (tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia and fatigue (tiredness). At the time of the report, pyrexia and fatigue (tiredness): not resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-043475 (patient link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Induration
Clinical narrative: bump on her temple; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (bump on her temple) in a 79-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INDURATION (bump on her temple). At the time of the report, INDURATION (bump on her temple) had resolved.            Concomitant medication were not provided. Treatment information was not provided.   This case was linked to MOD-2021-021449 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Genital blister, Myalgia, Oral herpes, Pyrexia
Clinical narrative: Genital and oral fever blisters; Genital and oral fever blisters; Restless leg syndrome; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drug was reported.  No Treatment  drug was reported.  Patient recently discovered that she might be autoimmune.
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: Genital and oral fever blisters; Genital and oral fever blisters; Restless leg syndrome; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, GENITAL BLISTER (Genital and oral fever blisters), ORAL HERPES (Genital and oral fever blisters), RESTLESS LEGS SYNDROME (Restless leg syndrome), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drug was reported.  No Treatment  drug was reported.  Patient recently discovered that she might be autoimmune.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Loss of appetite; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) in a 75-year-old male patient 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 OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) had resolved.            No relevant concomitant medication were provided. No treatment information was provided.   This case was linked to MOD-2021-024134 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Feeling abnormal, Product after taste, Throat tightness
Clinical narrative: Tasted medicine in mouth; Felt weak; Felt like throat was closing; Felt blurry; Hardly could breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Psoriasis (Patient takes the injection for Psoriasis).   On 02-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Tasted medicine in mouth). an unknown date, the patient experienced ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath). At the time of the report, DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), THROAT TIGHTNESS (Felt like throat was closing), FEELING ABNORMAL (Felt blurry) and DYSPNOEA (Hardly could breath) had resolved.            Two days before the vaccine, patient has taken injection for psoriasis.  No concomitant medications were reported. Treatment information was not provided.  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   Reporter did not allow further contact; 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
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (Baby ASPRIN), AMLODIPINE BESYLATE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish). At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. No concomitant product was provided by the reporter.  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: her daughter took the vaccine yesterday and is having nausea today; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (her daughter took the vaccine yesterday and is having nausea today) 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 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced NAUSEA (her daughter took the vaccine yesterday and is having nausea today). At the time of the report, NAUSEA (her daughter took the vaccine yesterday and is having nausea today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  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.   Reporter did not allow further contact; 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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered a dose of the Moderna COVID-19 vaccine from an expired vial.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered a dose of the Moderna COVID-19 vaccine from an expired vial.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered a dose of the Moderna COVID-19 vaccine from an expired vial.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered a dose of the Moderna COVID-19 vaccine from an expired vial.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of EXPIRED PRODUCT ADMINISTERED for mRNA-1273 (lot number unknown) with no associated AEs reported. Very limited information regarding this event has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients) 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 PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients). At the time of the report, PRODUCT STORAGE ERROR (We did not know that we had excursions from 6-1 to 6-18 and those vaccines were administered to patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received with non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate, Heart rate increased, Vaccination site erythema
Clinical narrative: Swelling at injection site; Redness at injection site; Rash at the injection site; Fatigue; Fast heart beat; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rash at the injection site) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Fatigue) and HEART RATE INCREASED (Fast heart beat). On 15-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, DIZZINESS (Dizzy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rash at the injection site), FATIGUE (Fatigue) and HEART RATE INCREASED (Fast heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, Heart rate: increased (High) Had a fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter said patient has not taken any medication for these symptoms.  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling at injection site; Redness at injection site; Rash at the injection site; Fatigue; Fast heart beat; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rash at the injection site) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Fatigue) and HEART RATE INCREASED (Fast heart beat). On 15-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE RASH (Rash at the injection site). At the time of the report, DIZZINESS (Dizzy), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rash at the injection site), FATIGUE (Fatigue) and HEART RATE INCREASED (Fast heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, Heart rate: increased (High) Had a fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter said patient has not taken any medication for these symptoms.  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.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; 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.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea, Skin warm, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: Pt stated he didn't like needles.  Post vaccine injection stated he felt warm and had nausea.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: Pt stated he didn't like needles.  Post vaccine injection stated he felt warm and had nausea.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and PYREXIA (Slight fever) in a 52-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Aches) and PYREXIA (Slight fever). At the time of the report, PAIN (Aches) and PYREXIA (Slight fever) had resolved.            Concomitant medications were not reported .  Treatment information was not provided   This case was linked to MOD-2021-028327 (Patient Link).   Reporter did not allow further contact; 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.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Electroencephalogram, Loss of consciousness, Magnetic resonance imaging, Paralysis
Clinical narrative: "Blacked" out, woke unable to speak words and was paralyzed from neck to feet. When the EMT arrived, I was able to try to barely say one syllable words.  I was taken to ER at hospital and a CT scan was taken. (Stroke or TIA was ruled out) No one could explain why the paralysis was on both sides of my body. Dr. mentioned a possible allergic reaction. After a few hours the paralysis began to subside, and I was able to speak in full sentences.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Speech disorder
Clinical narrative: "Blacked" out, woke unable to speak words and was paralyzed from neck to feet. When the EMT arrived, I was able to try to barely say one syllable words.  I was taken to ER at hospital and a CT scan was taken. (Stroke or TIA was ruled out) No one could explain why the paralysis was on both sides of my body. Dr. mentioned a possible allergic reaction. After a few hours the paralysis began to subside, and I was able to speak in full sentences.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram normal, Laboratory test normal, Paralysis, Speech disorder
Clinical narrative: "Blacked" out, woke unable to speak words and was paralyzed from neck to feet. When the EMT arrived, I was able to try to barely say one syllable words.  I was taken to ER at hospital and a CT scan was taken. (Stroke or TIA was ruled out) No one could explain why the paralysis was on both sides of my body. Dr. mentioned a possible allergic reaction. After a few hours the paralysis began to subside, and I was able to speak in full sentences.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: sore arm; bad headache; fever of 37.9; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included ERYTHROMYCIN for Wisdom teeth removal.    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 MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9). At the time of the report, MYALGIA (sore arm), HEADACHE (bad headache) and PYREXIA (fever of 37.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.9 degree Celsius (High) 37.9 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication reported  Additional information removed by the reporter was that the Patient had her wisdom teeth removed last week. Reporter wanted to know were there any risk taking antibiotics at the same time as that of vaccination.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Posture abnormal, Pyrexia, Vaccination complication, Vaccination site pain
Clinical narrative: felt horrible; bended over; Vaccination site pain; fever; side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt horrible), POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION COMPLICATION (side effect) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (felt horrible) and VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (felt horrible), POSTURE ABNORMAL (bended over), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION COMPLICATION (side effect) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up was received New AE Side effect was added Duration was 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.  More information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; Little bit of skin Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy) and RASH (Little bit of skin Rash) in a male 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. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (Little bit of skin Rash). At the time of the report, PRURITUS (Itchy) and RASH (Little bit of skin Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient advised urgent doctor put him on steroid and cream with no further information listed.; 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.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: second dose to a patient that was past 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose to a patient that was past 24 hours) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose to a patient that was past 24 hours). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (second dose to a patient that was past 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea, Visual impairment
Clinical narrative: I have had muscle aches the past two days; I have had dizziness immediately when I move my head backwards or too much forward, the past two days; I have had nausea the past two days; I have had sight problems the past two days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days). At the time of the report, MYALGIA (I have had muscle aches the past two days), DIZZINESS (I have had dizziness immediately when I move my head backwards or too much forward, the past two days), NAUSEA (I have had nausea the past two days) and VISUAL IMPAIRMENT (I have had sight problems the past two days) outcome was unknown.         No relevant concomitant medication was reported. The treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Uknown) was not applicable.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: felt dizzy , like of balance dizzy; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired) in an 82-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired). At the time of the report, DIZZINESS (felt dizzy , like of balance dizzy) and FATIGUE (extremely tired) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter. Upon in internal review on 04-Aug-2021, the age was corrected to 82 years   This case was linked to MOD-2021-054609 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up received on 15-07-2021 contain non significant information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site rash
Clinical narrative: hives; developed hives and red blotches around the vaccinated area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area). At the time of the report, URTICARIA (hives) and VACCINATION SITE RASH (developed hives and red blotches around the vaccinated area) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications used were not reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient receives expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient receives expired vaccine) 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 (patient receives expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient receives expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter.  No Treatment information were reported by the reporter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: Pfizer vaccine 1st dose, Moderna 2nd dose; Two different manufacturers given; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer vaccine 1st dose, Moderna 2nd dose) and WRONG PRODUCT ADMINISTERED (Two different manufacturers given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Followup received on 15 Jul 2021:contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received 1st dose in March and it's been past 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received 1st dose in March and it's been past 42 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received 1st dose in March and it's been past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received 1st dose in March and it's been past 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received updated reporter contact information and is considered non-significant.