chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, Headache, Myalgia
Clinical narrative: receive my second shot on July 8th I have been with side"; "muscular aches in all body; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (receive my second shot on July 8th I have been with side"), MYALGIA ("muscular aches in all body) and HEADACHE (headache) 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 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (receive my second shot on July 8th I have been with side "), MYALGIA ("muscular aches in all body) and HEADACHE (headache). At the time of the report, ADVERSE REACTION (receive my second shot on July 8th I have been with side), MYALGIA ("muscular aches in all body) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Temperature was up to 102 since 3 days ago..         No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site discomfort
Clinical narrative: like there is something in the injection site; recurring uncomfortable feeling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling). At the time of the report, VACCINATION SITE DISCOMFORT (like there is something in the injection site) and FEELING ABNORMAL (recurring uncomfortable feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication provided by the reporter was  cholesterol medication.  No Treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling, Vaccination complication
Clinical narrative: I had a slight reaction in my left upper arm; red; Some swelling; hot to the touch; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), ERYTHEMA (red), SWELLING (Some swelling), FEELING HOT (hot to the touch) and PRURITUS (itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), ERYTHEMA (red), SWELLING (Some swelling), FEELING HOT (hot to the touch) and PRURITUS (itchy). At the time of the report, VACCINATION COMPLICATION (I had a slight reaction in my left upper arm), SWELLING (Some swelling) and FEELING HOT (hot to the touch) outcome was unknown, ERYTHEMA (red) had not resolved and PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of vaccine almost one month ago. Patient had reactions for about 1-2 weeks. No concomitant treatment information were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Didn't get second dose, can I still get it; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it) 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 PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get second dose, can I still get it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: raised crusty bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (raised crusty bump) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0xgl21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 VACCINATION SITE SWELLING (raised crusty bump). At the time of the report, VACCINATION SITE SWELLING (raised crusty bump) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: never received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 (never received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never received 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.   No concomitant and treatment medication was reported by patient.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sometimes he says he can't move his left arm; Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes; excruciating pain in left arm that won't go away ,sometimes into his lower arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm), MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Jan-2021. Concomitant products included ATORVASTATIN, METFORMIN and AMLODIPINE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm). On an unknown date, the patient experienced MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes). At the time of the report, PAIN IN EXTREMITY (excruciating pain in left arm that won't go away ,sometimes into his lower arm), MOBILITY DECREASED (Sometimes he says he can't move his left arm) and ARTHRALGIA (Pain goes up to his shoulder joint and down to his elbow,Pain in right shoulder sometimes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported. patient stated that pain is still ongoing on 28-aug-2021.   This case was linked to MOD-2021-259987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received on 27-aug-2021. contains patient history, concomitant medication, date of onset and outcome of the event were added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Product dose omission issue
Clinical narrative: Infections; Patient missed her second dose (more than 11 weeks since first dose); This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infections) and PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0112196) for COVID-19 vaccination.     The patient's past medical history included Surgery (opening in stomach).    On 29-Apr-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 PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)). On an unknown date, the patient experienced INFECTION (Infections). On 19-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed her second dose (more than 11 weeks since first dose)) had resolved. At the time of the report, INFECTION (Infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included antibiotics. No Treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations, Product dose omission issue, Sinus disorder
Clinical narrative: Heart palpitations; Migraine headaches; sinus issue; No second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), MIGRAINE (Migraine headaches), SINUS DISORDER (sinus issue) and PRODUCT DOSE OMISSION ISSUE (No second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-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 PALPITATIONS (Heart palpitations), MIGRAINE (Migraine headaches), SINUS DISORDER (sinus issue) and PRODUCT DOSE OMISSION ISSUE (No second dose). At the time of the report, PALPITATIONS (Heart palpitations), MIGRAINE (Migraine headaches) and SINUS DISORDER (sinus issue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (No second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: Many of my IBS; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Many of my IBS) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Many of my IBS). At the time of the report, IRRITABLE BOWEL SYNDROME (Many of my IBS) outcome was unknown.            Concomitant information was not reported Treatment information was not  reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My wife had 1st mordena  in last jan and got serious reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My wife had 1st mordena  in last jan and got serious reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My wife had 1st mordena  in last jan and got serious reaction). At the time of the report, VACCINATION COMPLICATION (My wife had 1st mordena  in last jan and got serious reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. The treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Impaired healing, Thermal burn, Vaccination site discharge
Clinical narrative: injection site leaking black stuff; arm not healed; Scald; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054G21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald). At the time of the report, VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A Student received the second dose of the vaccine 18 days from the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A Student received the second dose of the vaccine 18 days from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication used were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up document  received contains No New Information
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Forgot to get her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19.    On 21-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 PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Forgot to get her second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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.   Concomitant medication was not reported. Treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Intentional product use issue, Muscle spasms, Musculoskeletal stiffness, Skin burning sensation
Clinical narrative: Burning; Sever cramping  in right  hand; Fingers were stiffed in the  morning; Has not received second dose due the side effects; Red wrinkled skin around his neck which got spread to his chest and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Burning ), MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning), INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning ) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder). an unknown date, the patient experienced MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning) and INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARAFFIN (VASELINE [PARAFFIN]) at an unspecified dose and frequency. At the time of the report, SKIN BURNING SENSATION (Burning ), MUSCLE SPASMS (Sever cramping  in right  hand), MUSCULOSKELETAL STIFFNESS (Fingers were stiffed in the  morning) and ERYTHEMA (Red wrinkled skin around his neck which got spread to his chest and shoulder) was resolving and INTENTIONAL PRODUCT USE ISSUE (Has not received second dose due the side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. Treatment medications included Steroid cream and herbal tea for arthritis along with above mentioned medications. Patient also had to do exercise to loosen joints and his stiffed fingers. Patient was supposed to receive the second dose of the Moderna Covid-19 vaccine on 13 July 2021.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Didn't receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose). On 19-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported Adverse Event. Consent for follow-up Denied by Patient. He recieved the first dose but didnt go back for second dose.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: was suppose to get my second shot in march; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march) 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 19-Jul-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No other adverse events were reported No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received a Second dose, 6 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received a Second dose, 6 months after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Depressed mood, Discomfort, Feeling hot, Hyperhidrosis
Clinical narrative: a warm sensation down his left arm then the rest of his body; uncomfortable after the injection/felt disgusting/He stated he felt bad; became extremely sick/vaccine made him so sick; stayed in bed for 3 days with fever; no energy; sweating; got depressed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever) and ASTHENIA (no energy) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, HYDROXYZINE, MELATONIN and PRAZOSIN for an unknown indication.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed). The patient was treated with IBUPROFEN for Fever, at a dose of 600 milligram. On 28-Jun-2021, PYREXIA (stayed in bed for 3 days with fever) had resolved. At the time of the report, FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed) 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: a warm sensation down his left arm then the rest of his body; uncomfortable after the injection/felt disgusting/He stated he felt bad; became extremely sick/vaccine made him so sick; stayed in bed for 3 days with fever; no energy; sweating; got depressed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever) and ASTHENIA (no energy) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, HYDROXYZINE, MELATONIN and PRAZOSIN for an unknown indication.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), PYREXIA (stayed in bed for 3 days with fever), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed). The patient was treated with IBUPROFEN for Fever, at a dose of 600 milligram. On 28-Jun-2021, PYREXIA (stayed in bed for 3 days with fever) had resolved. At the time of the report, FEELING HOT (a warm sensation down his left arm then the rest of his body), DISCOMFORT (uncomfortable after the injection/felt disgusting/He stated he felt bad), VACCINATION COMPLICATION (became extremely sick/vaccine made him so sick), ASTHENIA (no energy), HYPERHIDROSIS (sweating) and DEPRESSED MOOD (got depressed) 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.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was given on the 34th day after the vial was thawed; Dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose was given on the 34th day after the vial was thawed) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Dose was given on the 34th day after the vial was thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients given expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) 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 EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses) 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.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: metallic taste in the mouth/mouthful of dirty nickels; metallic smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell). At the time of the report, DYSGEUSIA (metallic taste in the mouth/mouthful of dirty nickels) and PAROSMIA (metallic smell) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.  Patient used to like coffee but now he cannot stand it.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received 2nd dose from a vial that was open for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours) in a 47-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 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2nd dose from a vial that was open for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: after the 2nd injection severe pain at the injection site/right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm) 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 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm). At the time of the report, VACCINATION SITE PAIN (after the 2nd injection severe pain at the injection site/right arm) outcome was unknown.            No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-260047 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Some soreness and pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Some soreness and pain in the injection arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in November 2020.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Some soreness and pain in the injection arm). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 milligram. At the time of the report, MYALGIA (Some soreness and pain in the injection arm) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-259974 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: sore arm; chills; headache; dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed), VACCINATION SITE PAIN (sore arm), CHILLS (chills) and HEADACHE (headache) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021 at 1:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm), CHILLS (chills) and HEADACHE (headache). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency. On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: no (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow up received included patient demographics, contact information updated and updated stop date of the event dose was given on the 34th day after the vial was thawed, Lab data updated, 2nd dose time updated.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: I had my first injection of the vaccine in April. I have not had my second one.; had COVID; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first injection of the vaccine in April. I have not had my second one.) and COVID-19 (had COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     submitted Adverse Event for follow up declined by Patient."Patient had their first injection of the vaccine in April. Patient have not had their second one. Patient also had COVID.  Patient is asking Should  take the second injection now or start all over?"
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Pyrexia, Rhinorrhoea
Clinical narrative: fever; chills; runny nose; chest tightness; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 26-Jan-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 PYREXIA (fever), CHILLS (chills), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form; ANTIHISTAMINES for Runny nose, at a dose of UNK dosage form and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Tight chest, at a dose of UNK dosage form. At the time of the report, PYREXIA (fever), CHILLS (chills), RHINORRHOEA (runny nose) and CHEST DISCOMFORT (chest tightness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 41.667 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were reported that is patient Is currently on blood pressure, cholesterol, anxiety and meds to help sleep.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient is 3 weeks past due date for the second dose; 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 is 3 weeks past due date for 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 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 (patient is 3 weeks past due date for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient is 3 weeks past due date for the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time; 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 received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient received 1st dose of the Moderna vaccine on January and didn't receive 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-JUL-2021 and reporter information was updated
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Limb discomfort, Nausea, Pain in extremity, Urticaria
Clinical narrative: hives; diarrhea; heaviness in the legs from the knee down/it feels like she is lugging pounds of weight; soreness in the arm, she said on the first day she could not feel her left arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), DIARRHOEA (diarrhea), LIMB DISCOMFORT (heaviness in the legs from the knee down/it feels like she is lugging pounds of weight), PAIN IN EXTREMITY (soreness in the arm, she said on the first day she could not feel her left arm) and NAUSEA (nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced URTICARIA (hives), DIARRHOEA (diarrhea), LIMB DISCOMFORT (heaviness in the legs from the knee down/it feels like she is lugging pounds of weight), PAIN IN EXTREMITY (soreness in the arm, she said on the first day she could not feel her left arm) and NAUSEA (nausea). 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, URTICARIA (hives), DIARRHOEA (diarrhea), LIMB DISCOMFORT (heaviness in the legs from the knee down/it feels like she is lugging pounds of weight), PAIN IN EXTREMITY (soreness in the arm, she said on the first day she could not feel her left arm) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included birth control medications.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well; 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 THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient contracted Covid disease in December 2020, since then felt shortness of breath and extreme fatigue.) in December 2020.    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 THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (On July 16 , 2021 he took the first dose of the Moderna vaccine, Since then the patient has been feeling very well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 8 weeks since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (8 weeks since 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 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 PRODUCT DOSE OMISSION ISSUE (8 weeks since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (8 weeks since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. Treatment information was not provided.