chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Impaired driving ability, Influenza like illness, Insomnia, Loss of personal independence in daily activities
Clinical narrative: injection site left arm has a bump; arm pain interrupts sleep; I feel like I have the flu; I have no energy; I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers; I am not able to drive a car; I am not able to work; my heart races; left arm hurts; I feel achy; left arm itches; left arm is red; left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy) and MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen). At the time of the report, VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Myalgia, Palpitations, Vaccination site erythema, Vaccination site mass
Clinical narrative: injection site left arm has a bump; arm pain interrupts sleep; I feel like I have the flu; I have no energy; I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers; I am not able to drive a car; I am not able to work; my heart races; left arm hurts; I feel achy; left arm itches; left arm is red; left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy) and MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen). At the time of the report, VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site left arm has a bump; arm pain interrupts sleep; I feel like I have the flu; I have no energy; I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers; I am not able to drive a car; I am not able to work; my heart races; left arm hurts; I feel achy; left arm itches; left arm is red; left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy) and MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen). At the time of the report, VACCINATION SITE MASS (injection site left arm has a bump), INSOMNIA (arm pain interrupts sleep), INFLUENZA LIKE ILLNESS (I feel like I have the flu), ASTHENIA (I have no energy), MEMORY IMPAIRMENT (I am having trouble with memory/I am having trouble with remembering some tasks/I am not able to remember telephone numbers), IMPAIRED DRIVING ABILITY (I am not able to drive a car), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I am not able to work), PALPITATIONS (my heart races), VACCINATION SITE PAIN (left arm hurts), MYALGIA (I feel achy), VACCINATION SITE PRURITUS (left arm itches), VACCINATION SITE ERYTHEMA (left arm is red) and VACCINATION SITE SWELLING (left arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; 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 EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) in a 31-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 14-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 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product details were provided by the reporter. No Treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Injection site pain
Clinical narrative: not feeling really well; injection site is very sore; Armpit became very sore; Fever; Joint pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever) and ARTHRALGIA (Joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history Information was provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID and FLUOXETINE for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: not feeling really well; injection site is very sore; Armpit became very sore; Fever; Joint pain; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever) and ARTHRALGIA (Joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history Information was provided.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID and FLUOXETINE for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, MALAISE (not feeling really well), INJECTION SITE PAIN (injection site is very sore), AXILLARY PAIN (Armpit became very sore), PYREXIA (Fever), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Someone passed away after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Someone passed away after getting the vaccine) in a 65-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient died the day after receiving the Moderna Covid-19 vaccine.  Very limited information regarding this event has been provided at this time.  Further information can't  be requested (No consent for safety follow-up).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information can't  be requested (No consent for safety follow-up).; Reported Cause(s) of Death: Unknown cause of death
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient had a home antigen test for covid, which was positive; 99.6°F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had a home antigen test for covid, which was positive) and PYREXIA (99.6°F) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced PYREXIA (99.6°F). On 13-Aug-2021, the patient experienced COVID-19 (Patient had a home antigen test for covid, which was positive). At the time of the report, COVID-19 (Patient had a home antigen test for covid, which was positive) and PYREXIA (99.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 99.6 (High) 99.6 degree F.. On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) positive for covid19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided Before the vaccine was given, on 7Aug2021, the patient was tested negative for covid19. The caller wanted to know if the vaccine is less effective in this case or the effectiveness remains the same.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated; On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated) and DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine). On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated). At the time of the report, COVID-19 (Tested positive for COVID 19 after receiving both doses of the Moderna COVID 19 vaccine/Got COVID-19 after being vaccinated) and DRUG INEFFECTIVE (On 6AUG2021, 6 months after getting her 1st dose she tested positive for COVID19 vaccine) outcome was unknown.            Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: The follow up received does not contain any new information.; Sender's Comments: This is a case of Lack of efficacy as the patient had a positive COVID-19 test but it is unclear if the patient has any signs or symptoms of the disease. This may not be a case of LOE but since the patient refused follow-up this cannot be accurately determined. Based on current available information and the temporal association between both doses of the product and the start date of the events a causal relationship is not applicable for the event COVID-19 and possible for Drug ineffective.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Irritability, Nasal congestion, Pharyngeal swelling
Clinical narrative: Also congested from an allergy; It's annoying; Right eye swell up/in the beginning looked like a bug bite; Throat swell up; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (It's annoying), NASAL CONGESTION (Also congested from an allergy), EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) and PHARYNGEAL SWELLING (Throat swell up) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Systemic lupus erythematosus.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced IRRITABILITY (It's annoying). 12-Aug-2021, the patient experienced EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) and PHARYNGEAL SWELLING (Throat swell up). On an unknown date, the patient experienced NASAL CONGESTION (Also congested from an allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at an unspecified dose and frequency. At the time of the report, IRRITABILITY (It's annoying) and NASAL CONGESTION (Also congested from an allergy) outcome was unknown, EYE SWELLING (Right eye swell up/in the beginning looked like a bug bite) was resolving and PHARYNGEAL SWELLING (Throat swell up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Gesimppa, once a month injection, a new drug to treat multiple sclerosis and lupus.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Oropharyngeal pain
Clinical narrative: Sore throat; Inappropriate dose of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Topical adhesive allergy.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 5 milliliter. On 14-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered). On 14-Aug-2021, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) had resolved. On 15-Aug-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I had my first COVID shot in April./Would I still be able to get the second dose now?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first COVID shot in April./Would I still be able to get the second dose now?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment drug information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Pruritus, Vaccination site erythema
Clinical narrative: fatigue; Redness left arm; Sore left arm; joint pain left hip; itchy in the back; sweats; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the first episode of FATIGUE (fatigue), the second episode of FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Redness left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (itchy in the back), HYPERHIDROSIS (sweats) and the first episode of FATIGUE (fatigue). On 12-Aug-2021, the patient experienced the second episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE PAIN (Sore left arm). 12-Aug-2021, the patient experienced ARTHRALGIA (joint pain left hip). At the time of the report, PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the last episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE PAIN (Sore left arm) and ARTHRALGIA (joint pain left hip) outcome was unknown.            No Concomitant medication was reported.  No treatment was reported.  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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.   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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fatigue; Redness left arm; Sore left arm; joint pain left hip; itchy in the back; sweats; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the first episode of FATIGUE (fatigue), the second episode of FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Redness left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (itchy in the back), HYPERHIDROSIS (sweats) and the first episode of FATIGUE (fatigue). On 12-Aug-2021, the patient experienced the second episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE PAIN (Sore left arm). 12-Aug-2021, the patient experienced ARTHRALGIA (joint pain left hip). At the time of the report, PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the last episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE PAIN (Sore left arm) and ARTHRALGIA (joint pain left hip) outcome was unknown.            No Concomitant medication was reported.  No treatment was reported.  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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.   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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: rapid test that was positive for COVID-19; having temperature/temperature of 99.9°F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9°F) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PYREXIA (having temperature/temperature of 99.9°F). On 11-Aug-2021, the patient experienced COVID-19 (rapid test that was positive for COVID-19). At the time of the report, COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Aug-2021, Body temperature: 99.9 (High) 99.9 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   It was reported that patient had a polymer chain reaction (PCR) test and result pending at the time of this report.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Pyrexia
Clinical narrative: red spot in the middle of her forehead/red spot the size of a quarter; chills; fever of 101 Fahrenheit; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 004D21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (high blood pressure). Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit). At the time of the report, ERYTHEMA (red spot in the middle of her forehead/red spot the size of a quarter), CHILLS (chills) and PYREXIA (fever of 101 Fahrenheit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 101 (High) fever of 101 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: No new information
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait inability
Clinical narrative: So intense I couldn't walk; I began having pain in both my knees. It gradually got worse; I began having pain in both my knees; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees) 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 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees). At the time of the report, GAIT INABILITY (So intense I couldn't walk), CONDITION AGGRAVATED (I began having pain in both my knees. It gradually got worse) and ARTHRALGIA (I began having pain in both my knees) outcome was unknown.            No concomitant medications was reported. Treatment medications was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling face
Clinical narrative: side of face were swollen; itching on the neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MLS-319813_r) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck). At the time of the report, SWELLING FACE (side of face were swollen) and PRURITUS (itching on the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Dry throat
Clinical narrative: dry throat; This spontaneous case was reported by an other health care professional and describes the occurrence of DRY THROAT (dry throat) 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 DRY THROAT (dry throat). At the time of the report, DRY THROAT (dry throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported. No concomitant medication were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue, Vaccination site pain
Clinical narrative: General malaise; Vaccination site pain; patient never received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient never received the second dose). On an unknown date, the patient experienced MALAISE (General malaise) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, MALAISE (General malaise) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient never received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by the reporter  It was reported that the patient did not take any medications to treat the symptoms Patient was taking concomitant medications but refused to provide the information The patient reported that the symptoms lasted for about 3 to 4 days   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live-follow was received contains no new information
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Ocular discomfort
Clinical narrative: Vein under left  eye vibrating; Pinkie and ring finger (bottom half of hand) was numb; Twitches in triceps; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009CUA) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps). At the time of the report, OCULAR DISCOMFORT (Vein under left  eye vibrating), HYPOAESTHESIA (Pinkie and ring finger (bottom half of hand) was numb) and MUSCLE TWITCHING (Twitches in triceps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) in a 55-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 15-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 EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: little headache; I could barely lift my left arm; could barely walk; arm swollen; brain fog like I was out of it; metal taste in mouth; whole body hurt; muscle ache; so tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and PAIN (whole body hurt) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN (whole body hurt), MYALGIA (muscle ache) and FATIGUE (so tired). On 12-Aug-2021, the patient experienced GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and VACCINATION SITE PAIN (I could barely lift my left arm). On 13-Aug-2021, the patient experienced HEADACHE (little headache). At the time of the report, GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth), PAIN (whole body hurt), VACCINATION SITE PAIN (I could barely lift my left arm), MYALGIA (muscle ache), HEADACHE (little headache) and FATIGUE (so tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment medication were provided by reporter. Patient felt stuck on left arm and chest. Patient felt better on 13-Aug-2021. The patient felt that whole body was hurt on 12-Aug-2021.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Peripheral swelling, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: little headache; I could barely lift my left arm; could barely walk; arm swollen; brain fog like I was out of it; metal taste in mouth; whole body hurt; muscle ache; so tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and PAIN (whole body hurt) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN (whole body hurt), MYALGIA (muscle ache) and FATIGUE (so tired). On 12-Aug-2021, the patient experienced GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and VACCINATION SITE PAIN (I could barely lift my left arm). On 13-Aug-2021, the patient experienced HEADACHE (little headache). At the time of the report, GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth), PAIN (whole body hurt), VACCINATION SITE PAIN (I could barely lift my left arm), MYALGIA (muscle ache), HEADACHE (little headache) and FATIGUE (so tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter. No treatment medication were provided by reporter. Patient felt stuck on left arm and chest. Patient felt better on 13-Aug-2021. The patient felt that whole body was hurt on 12-Aug-2021.   Reporter did not allow further contact
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a vaccine which was more than 12 days in the refrigerator; Received a vaccine which was more than 12 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 13-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 12 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 12 days in the refrigerator) in a 41-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 15-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 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 12 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 12 days in the refrigerator). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 12 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 12 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a vaccine which was more than 30 days in the refrigerator; Received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) in a 32-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 15-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 EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  The patient received a vaccine which was 12 days in the refrigerator.