chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen arm) and pain in extremity (sore arm) in an 88-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 first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swollen arm) and pain in extremity (sore arm). At the time of the report, peripheral swelling (swollen arm) and pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. This case linked to MOD-2021-302671 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 3 days after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea 3 days after 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea 3 days after vaccine). At the time of the report, DIARRHOEA (Diarrhea 3 days after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter. No treatment medication provided by reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (3 heart attacks) and Stroke.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was unknown.  Patient  was vegan for 10 yrs now. And use no oils in his diet."   This case was linked to MOD-2021-302607 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown.            no concomitant medications are provided. treatment to the events not reported. patient wants to get the booster on 1-sep-2021.   This case was linked to MOD-2021-302521 (Patient Link).; Sender's Comments: Based on pathophysiology of the event urinary tract infection, the event is assessed as unlikely related to mRNA-1273.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Ache in her injection site arm; Slight fever; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE PAIN (Ache in her injection site arm), PYREXIA (Slight fever), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-302693 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Dizziness; Not feeling well; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     The patient's past medical history included Surgery on 27-May-2021. Concomitant products included TRAMADOL for an unknown indication.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Not feeling well) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Dizziness, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication: Tylenol 500mg morning and if needed two at bedtime for headache and dizziness, patient said this is not working. The patient woke up not feeling well, had relaxed since then. The patient had been, dizzy since then also headaches, the day after she got her first vaccine. The patient was still experiencing the dizziness and headaches.  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.; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen hands and feet severe pain; Swollen hands and feet severe pain; hurts to walk; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen hands and feet severe pain), PAIN IN EXTREMITY (Swollen hands and feet severe pain) and GAIT DISTURBANCE (hurts to walk) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054cz1a and 006d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands and feet severe pain), PAIN IN EXTREMITY (Swollen hands and feet severe pain) and GAIT DISTURBANCE (hurts to walk). At the time of the report, PERIPHERAL SWELLING (Swollen hands and feet severe pain) and PAIN IN EXTREMITY (Swollen hands and feet severe pain) had not resolved and GAIT DISTURBANCE (hurts to walk) outcome was unknown.            Concomitant medication were not provided. Treatment medication were not reported.  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: Appendicitis
Clinical narrative: appendicitis/ appendix removed; This spontaneous case was reported by a pharmacist and describes the occurrence of APPENDICITIS (appendicitis/ appendix removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 03-Aug-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) (unknown route) 1 dosage form. In August 2021, the patient experienced APPENDICITIS (appendicitis/ appendix removed) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (appendix removed) for Appendicitis. At the time of the report, APPENDICITIS (appendicitis/ appendix removed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.; 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Malaise, Myalgia
Clinical narrative: malaise; Myalgia; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Penicillin allergy, Foot drop, Skin lesion and Sleeplessness. Concomitant products included OCRELIZUMAB (OCREVUS), BUPROPION, FAMPRIDINE (AMPYRA), FISH OIL (OMEGA 3 FISH OILS), BACLOFEN and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue). At the time of the report, MALAISE (malaise), MYALGIA (Myalgia) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One dose given > 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (One dose given > 12 hours after puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient received the expired dose 8 hours passed the 12-hour expiration. The vial was initially stored in the refrigerator on 24 Aug 2021 (one week ago) and was removed from refrigerator, dose drawn up at room temperature, and then administered to the patient. Total amount of time the vial was exposed to room temperature range (46° to 77° F).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
Clinical narrative: I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).; I am 7 months pregnant.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) in a female 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days since patient's first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since patient's first dose) had resolved.            Concomitant medication was not provided Treatment information was not reported  Patient had an appointment for her second dose on 13 Aug 2021, but did not receive the second dose.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a 35-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-303281 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Infertility female
Clinical narrative: not to be able to get pregnant; This spontaneous case was reported by an other health care professional and describes the occurrence of INFERTILITY FEMALE (not to be able to get pregnant) in a 25-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFERTILITY FEMALE (not to be able to get pregnant). At the time of the report, INFERTILITY FEMALE (not to be able to get pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I became infected with Covid about 3 weeks after having had my first Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.). At the time of the report, COVID-19 (I became infected with Covid about 3 weeks after having had my first Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Agitation
Clinical narrative: agitation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AGITATION (agitation) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGITATION (agitation). At the time of the report, AGITATION (agitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling cold, Rash
Clinical narrative: almost passed out; body is cold; He's having a cold sweat, body is cold; He has a rash underneath both armpits; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (almost passed out), FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced DIZZINESS (almost passed out), FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (almost passed out) outcome was unknown and FEELING COLD (body is cold), COLD SWEAT (He's having a cold sweat, body is cold) and RASH (He has a rash underneath both armpits) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.  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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue
Clinical narrative: discomfort; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (discomfort) and FATIGUE (Tiredness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced DISCOMFORT (discomfort) and FATIGUE (Tiredness). At the time of the report, DISCOMFORT (discomfort) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment was not specified.   This case was linked to MOD-2021-303237 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Shaking inside; Nauseous; Vomiting; Got really sick at night; Dizzy; Weak/Feeling very weak; Confusion was high; Lot of stomach sore; Felt like being hit by a truck; Couldn't sleep; Her head was all over the place; Arms, legs and feet hurt a lot; Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak) and CONFUSIONAL STATE (Confusion was high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body). On 29-Aug-2021, the patient experienced ILLNESS (Got really sick at night), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting). On 30-Aug-2021, the patient experienced NAUSEA (Nauseous). On 31-Aug-2021, the patient experienced NERVOUSNESS (Shaking inside). On 24-Aug-2021, PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body) had resolved. On 30-Aug-2021, DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting) had resolved. At the time of the report, ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Illness, Insomnia, Nausea, Nervousness
Clinical narrative: Shaking inside; Nauseous; Vomiting; Got really sick at night; Dizzy; Weak/Feeling very weak; Confusion was high; Lot of stomach sore; Felt like being hit by a truck; Couldn't sleep; Her head was all over the place; Arms, legs and feet hurt a lot; Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak) and CONFUSIONAL STATE (Confusion was high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body). On 29-Aug-2021, the patient experienced ILLNESS (Got really sick at night), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting). On 30-Aug-2021, the patient experienced NAUSEA (Nauseous). On 31-Aug-2021, the patient experienced NERVOUSNESS (Shaking inside). On 24-Aug-2021, PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body) had resolved. On 30-Aug-2021, DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting) had resolved. At the time of the report, ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vomiting
Clinical narrative: Shaking inside; Nauseous; Vomiting; Got really sick at night; Dizzy; Weak/Feeling very weak; Confusion was high; Lot of stomach sore; Felt like being hit by a truck; Couldn't sleep; Her head was all over the place; Arms, legs and feet hurt a lot; Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak) and CONFUSIONAL STATE (Confusion was high) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body). On 29-Aug-2021, the patient experienced ILLNESS (Got really sick at night), DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting). On 30-Aug-2021, the patient experienced NAUSEA (Nauseous). On 31-Aug-2021, the patient experienced NERVOUSNESS (Shaking inside). On 24-Aug-2021, PARAESTHESIA (Tingling sensation on one of her sides/ this sensation was all over her body/Still has tingling sensation on body) had resolved. On 30-Aug-2021, DIZZINESS (Dizzy), ASTHENIA (Weak/Feeling very weak), CONFUSIONAL STATE (Confusion was high), ABDOMINAL PAIN UPPER (Lot of stomach sore), FEELING ABNORMAL (Felt like being hit by a truck), INSOMNIA (Couldn't sleep), HEAD DISCOMFORT (Her head was all over the place), PAIN IN EXTREMITY (Arms, legs and feet hurt a lot) and VOMITING (Vomiting) had resolved. At the time of the report, ILLNESS (Got really sick at night), NERVOUSNESS (Shaking inside) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Feeling abnormal, Headache
Clinical narrative: Missed second shot, about 4 months post first shot; Bad Headache after first vaccine; Chronic Fatigue came back after first vaccine; Joint pain came back after first vaccine; felt like had the flu after first vaccine; had no strength after first vaccine; Brain Fog came back after first vaccine; Chronic Migraine came back after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot) in a 64-year-old male patient 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 Chronic fatigue syndrome, Foggy feeling in head (Brain fog), Chronic migraine (25 Days a month from a virus since 20 years), Joint pain and Fibromyalgia. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot). At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He did not take the second dose because of side effects of first dose but as his family have no side effects he is tempted to take the second dose of vaccine. Treatment information was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Product dose omission issue
Clinical narrative: Missed second shot, about 4 months post first shot; Bad Headache after first vaccine; Chronic Fatigue came back after first vaccine; Joint pain came back after first vaccine; felt like had the flu after first vaccine; had no strength after first vaccine; Brain Fog came back after first vaccine; Chronic Migraine came back after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot) in a 64-year-old male patient 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 Chronic fatigue syndrome, Foggy feeling in head (Brain fog), Chronic migraine (25 Days a month from a virus since 20 years), Joint pain and Fibromyalgia. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot). At the time of the report, INFLUENZA LIKE ILLNESS (felt like had the flu after first vaccine), ASTHENIA (had no strength after first vaccine), FEELING ABNORMAL (Brain Fog came back after first vaccine), MIGRAINE (Chronic Migraine came back after first vaccine), PRODUCT DOSE OMISSION ISSUE (Missed second shot, about 4 months post first shot), HEADACHE (Bad Headache after first vaccine), FATIGUE (Chronic Fatigue came back after first vaccine) and ARTHRALGIA (Joint pain came back after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       He did not take the second dose because of side effects of first dose but as his family have no side effects he is tempted to take the second dose of vaccine. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Keratosis pilaris, Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash is a little bit itchy every so often; the rash turns very red, like scars shape like rings; little bumps on their chest; horrible rash on the base of the neck/rash all around the neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) 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) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck). At the time of the report, RASH PRURITIC (rash is a little bit itchy every so often), RASH ERYTHEMATOUS (the rash turns very red, like scars shape like rings), KERATOSIS PILARIS (little bumps on their chest) and RASH (horrible rash on the base of the neck/rash all around the neck) had not resolved.            No relevant concomitant medications were reported.  Patient was undergone a Biopsy but results were unavailable.  Patient was treating with steroid injections and steroid cream.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hypersomnia
Clinical narrative: She could not get warm, she was bone cold; She slept a lot; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 0LGL20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, MIRABEGRON (MYRBETRIQ), ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted). At the time of the report, FEELING COLD (She could not get warm, she was bone cold), HYPERSOMNIA (She slept a lot) and FATIGUE (Exhausted) outcome was unknown.            Patient reported that she was asthmatic at baseline.   She had COVID-19 before first dose.  No treatment medications were reported
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Haematochezia, Myalgia, Pyrexia
Clinical narrative: Blood in the stool; Hives all over her legs/Hives spread to arms and lips; Chills; Body aches; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever 100F). On 31-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant) and URTICARIA (Hives all over her legs/Hives spread to arms and lips). On 30-Aug-2021, PYREXIA (Fever 100F) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in the stool), URTICARIA (Hives all over her legs/Hives spread to arms and lips), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient experienced fever, chills and body aches.On 31 Aug 2021,in the morning she noticed hives all over her legs but there were no itching and in the evening the hives were also on her arms and lips.No treatment information was 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.; 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Blood in the stool; Hives all over her legs/Hives spread to arms and lips; Chills; Body aches; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever 100F). On 31-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant) and URTICARIA (Hives all over her legs/Hives spread to arms and lips). On 30-Aug-2021, PYREXIA (Fever 100F) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in the stool), URTICARIA (Hives all over her legs/Hives spread to arms and lips), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient experienced fever, chills and body aches.On 31 Aug 2021,in the morning she noticed hives all over her legs but there were no itching and in the evening the hives were also on her arms and lips.No treatment information was 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.; 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission
Clinical narrative: she never went to get her 2nd dose after receiving the first.; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.). On 16-May-2021, INTENTIONAL DOSE OMISSION (she never went to get her 2nd dose after receiving the first.) had resolved.            It was stated that she did not experience any adverse reactions with the 1st dose. She was not taking any concomitant medications at this time.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Pain
Clinical narrative: extremely cold; weak; achy; This spontaneous case was reported by a nurse and describes the occurrence of FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy) 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 30-Aug-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) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. At the time of the report, FEELING COLD (extremely cold), ASTHENIA (weak) and PAIN (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Visual impairment
Clinical narrative: Eyes started burning (Not sure if vaccine related); Eyes started itching (Not sure if vaccine related); Vision fades sometimes (Not sure if vaccine related); This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)). At the time of the report, EYE IRRITATION (Eyes started burning (Not sure if vaccine related)), EYE PRURITUS (Eyes started itching (Not sure if vaccine related)) and VISUAL IMPAIRMENT (Vision fades sometimes (Not sure if vaccine related)) outcome was unknown.            Patient stated that for the above mentioned events if she blinks, it gets back to normal. Patient didn't saw her doctor since June2021 and in June her vision was healthy. Her blood sugar had been normal after vaccination and it did not fluctuate. No concomitant medications were mentioned. No treatment details were reported.