chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash
Clinical narrative: Rash in her face after the vaccine; More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash in her face after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in her face after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose). At the time of the report, RASH (Rash in her face after the vaccine) and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose, past the 42 day mark; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Wheelchair user.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, past the 42 day mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) 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 ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. Patient reported upset stomach after eating some Mexican food.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional distress, Malaise, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Pain in arm; He is in some level of distress/  really bothered by it, and this was something that is unusual for him; did not feel good for a couple days; His son felt very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (6 to 8 weeks before vaccination. Got quite sick at that point and recovered). Concomitant products included VITAMINS NOS for an unknown indication.    In July 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 PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), EMOTIONAL DISTRESS (He is in some level of distress/  really bothered by it, and this was something that is unusual for him), MALAISE (did not feel good for a couple days) and MYALGIA (His son felt very sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received and added start date of vaccine, added concomitant medication. added new events.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash
Clinical narrative: more than 35 days since first dose; Itchy; Rash in chest; rash in forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (experienced an anaphylactic reaction to Amoxicillin). Concomitant products included VITAMINS NOS, UBIDECARENONE (VITAMATE COENZYME Q10) and VITAMIN D NOS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 15-Jan-2021, PRODUCT DOSE OMISSION ISSUE (more than 35 days since first dose), PRURITUS (Itchy), RASH (Rash in chest) and RASH (rash in forehead) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that  one or two hours after first dose ,patient experienced rash on forehead, chest and itch. And symptoms lasted for an hour. Patient stated her doctor advised not to take second dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication
Clinical narrative: Expired Vaccine administered; 1 Patient is having side effects; 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 (Expired Vaccine administered) and VACCINATION COMPLICATION (1 Patient is having side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) and VACCINATION COMPLICATION (1 Patient is having side effects). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) had resolved and VACCINATION COMPLICATION (1 Patient is having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-261682 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received 27-JUL-2021, No new information On 10-Sep-2021: Follow-up document received contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Ear infection, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Ear infection; delayed the second dose vaccination/beyond the 6 weeks period, 60 days after; Patient has not received 2nd dose, received first dose 1Jun2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021), EAR INFECTION (Ear infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after) 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 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 01-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021). On an unknown date, the patient experienced EAR INFECTION (Ear infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose, received first dose 1Jun2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed the second dose vaccination/beyond the 6 weeks period, 60 days after) had resolved and EAR INFECTION (Ear infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  Patient had taken the antibiotic for treatment of ear infection hence delayed in 2nd dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up  received on 30-JUL-2021: New event of Ear infection and treatment medication were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Somnolence
Clinical narrative: wiped out the day afterwards; tired; uncomfortable; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy), FATIGUE (wiped out the day afterwards) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy) and FATIGUE (tired). On 25-Feb-2021, the patient experienced FATIGUE (wiped out the day afterwards). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy), FATIGUE (wiped out the day afterwards) and FATIGUE (tired) outcome was unknown.            Concomitant medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: has seen people with some rashes with the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of RASH (has seen people with some rashes with the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (has seen people with some rashes with the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (has seen people with some rashes with the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: little swollen left arm; went anxious; almost trembling; left arm hurts a little; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (little swollen left arm), ANXIETY (went anxious), TREMOR (almost trembling) and PAIN IN EXTREMITY (left arm hurts a little) 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 20-Jul-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 20-Jul-2021, the patient experienced PERIPHERAL SWELLING (little swollen left arm), ANXIETY (went anxious), TREMOR (almost trembling) and PAIN IN EXTREMITY (left arm hurts a little). At the time of the report, PERIPHERAL SWELLING (little swollen left arm), ANXIETY (went anxious), TREMOR (almost trembling) and PAIN IN EXTREMITY (left arm hurts a little) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered; 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 (Expired Vaccine administered) 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 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Caught Covid-19 after vaccination; "Greater than 35 days between doses of Moderna Covid-19 vaccine"; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid-19 after vaccination) and PRODUCT DOSE OMISSION ISSUE ("Greater than 35 days between doses of Moderna Covid-19 vaccine") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE ("Greater than 35 days between doses of Moderna Covid-19 vaccine"). On 13-Jan-2021, the patient experienced COVID-19 (Caught Covid-19 after vaccination). At the time of the report, COVID-19 (Caught Covid-19 after vaccination) outcome was unknown and PRODUCT DOSE OMISSION ISSUE ("Greater than 35 days between doses of Moderna Covid-19 vaccine") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication were reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: s it normal to feel achy and achy after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (s it normal to feel achy and achy after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (s it normal to feel achy and achy after 1st dose). At the time of the report, MYALGIA (s it normal to feel achy and achy after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Tenderness
Clinical narrative: pain in armpit; a knot under left armpit; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE, SPIRONOLACTONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness). The patient was treated with IBUPROFEN at a dose of 3 dosage form every six hours. At the time of the report, AXILLARY PAIN (pain in armpit), AXILLARY MASS (a knot under left armpit) and TENDERNESS (Tenderness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: I have a red blotchy arm 2 days after the moderna vaccine?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (I have a red blotchy arm 2 days after the moderna 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH MACULAR (I have a red blotchy arm 2 days after the moderna vaccine?). At the time of the report, RASH MACULAR (I have a red blotchy arm 2 days after the moderna vaccine?) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Lethargy, Pain in extremity
Clinical narrative: pain is on his right leg with a pain scale of 8.5/10; Feels lethargic; Joint pain on right leg; Flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN IN EXTREMITY (pain is on his right leg with a pain scale of 8.5/10), LETHARGY (Feels lethargic) and ARTHRALGIA (Joint pain on right leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: 5 female patients administered expired dose (6 days beyond use date); Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)) and PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21). On 23-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)). On 23-Jun-2021, PRODUCT ADMINISTRATION ERROR (5 female patients administered expired dose (6 days beyond use date)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Moved from frozen storage to refrigerated storage on 5/17/21 and kept between 2 and 8 degree C. The vaccine was administered on 6/23/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.; Sender's Comments: This report refers to a case of product storage error and product administration error for mRNA-1273, lot # 035C21A with no associated AEs
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product administered to patient of inappropriate age
Clinical narrative: She just turned 17 and the health department gave her maderna shot; She was so sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She was so sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    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 ILLNESS (She was so sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot). At the time of the report, ILLNESS (She was so sick) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She just turned 17 and the health department gave her maderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non-significant follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Poor Appetite; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Poor Appetite) and FATIGUE (Tiredness) 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 18-Mar-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 DECREASED APPETITE (Poor Appetite) and FATIGUE (Tiredness). At the time of the report, DECREASED APPETITE (Poor Appetite) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Scheduled to receive dose second 21 days after first dose; A Little Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A Little Arm Pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose) 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 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced PAIN IN EXTREMITY (A Little Arm Pain). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose). At the time of the report, PAIN IN EXTREMITY (A Little Arm Pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Scheduled to receive dose second 21 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment was received by the patient.   No Concomitant medication was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received : Contains No new information
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Extrasystoles, Headache, Hypertension
Clinical narrative: Her blood pressure was 200/over something; A rapid heartbeat; She was having a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 028L201A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE, MELOXICAM, SIMVASTATIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.   On 23-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 09-May-2021, the patient experienced HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache). At the time of the report, HYPERTENSION (Her blood pressure was 200/over something), EXTRASYSTOLES (A rapid heartbeat) and HEADACHE (She was having a bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: high (High) blood pressure was 200/over.         Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: "2 different neurologists I have seen say they have treated patients who have had tremors for weeks"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR ("2 different neurologists I have seen say they have treated patients who have had tremors for weeks") 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 TREMOR ("2 different neurologists I have seen say they have treated patients who have had tremors for weeks"). At the time of the report, TREMOR ("2 different neurologists I have seen say they have treated patients who have had tremors for weeks") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. Treatment information was not provided.    This case was linked to MOD21-121801 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Excessive Sweating after the Second Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Excessive Sweating after the Second 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 was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Excessive Sweating after the Second Vaccine). At the time of the report, HYPERHIDROSIS (Excessive Sweating after the Second Vaccine) outcome was unknown.            No relevant concomitant medications were reported  No treatment information was provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was moved from frozen storage to refrigerated storage; administered expired dose (6 days beyond use date); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)) and PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received information included dose number and first dose information was updated. Patient demographics was added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: excruciating pain in the back/lower back pain; spasming when she was trying to sit down or stand up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No medical history provided by the reporter.     On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (excruciating pain in the back/lower back pain) and MUSCLE SPASMS (spasming when she was trying to sit down or stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 20-JUL-2021 and contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my upper left thigh. Looked like a lot of little chicken scratches/Very rough to touch.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my upper left thigh. Looked like a lot of little chicken scratches/Very rough to touch.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced RASH (Rash on my upper left thigh. Looked like a lot of little chicken scratches/Very rough to touch.). At the time of the report, RASH (Rash on my upper left thigh. Looked like a lot of little chicken scratches/Very rough to touch.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-032409 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: upper right arm is hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper right arm is hurting really bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (upper right arm is hurting really bad). At the time of the report, PAIN IN EXTREMITY (upper right arm is hurting really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported. Patient is not on any Concomitant medication.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: half of the residents have had a bad reaction to the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna 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 VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (half of the residents have had a bad reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Felt tired after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, Flonase and CETIRIZINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FATIGUE (Felt tired after first dose). At the time of the report, FATIGUE (Felt tired after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO treatment information was provided by the reporter.   This case was linked to MOD-2021-261749 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: only had sniffles the first night; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (only had sniffles the first night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (only had sniffles the first night). At the time of the report, RHINORRHOEA (only had sniffles the first night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2021-260257 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19 after receiving 1st dose of the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.). At the time of the report, COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, SARS-CoV-2 test: tested positive for covid (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past BUD) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C2A1) 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) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past BUD) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant products were reported by the reporter. Upon internal review on 04-Aug-2021, the age was corrected to 18 years.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Oropharyngeal pain, Productive cough, SARS-CoV-2 test
Clinical narrative: Sore throat; cough; mucus in lungs; Felt tired after second dose; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (cough), PRODUCTIVE COUGH (mucus in lungs) and FATIGUE (Felt tired after second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and CETIRIZINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (Felt tired after second dose). On 09-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (cough) and PRODUCTIVE COUGH (mucus in lungs). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (cough) and PRODUCTIVE COUGH (mucus in lungs) outcome was unknown and FATIGUE (Felt tired after second dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: sars-cov-1 test (Positive) COVID 19 positive.         No treatment medication was provided by the reporter.   This case was linked to MOD-2021-261738 (Patient Link).