chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: it's been more than 42 days after the first dose without receiving the second dose; had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid) and PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days after the first dose without receiving the 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (had covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days after the first dose without receiving the second dose). At the time of the report, COVID-19 (had covid) and PRODUCT DOSE OMISSION ISSUE (it's been more than 42 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.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  The patient needed an antibodies infusion for Covid, and reporter wanted to know if it is necessary for patient to have a second dose of the Moderna Covid19 Vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram head, Dehydration, Gastrointestinal disorder, Loss of consciousness
Clinical narrative: gastrointestinal symptoms; fever of 103 F; seizure like activity; profound wave of nausea, passed out; profound wave of nausea, passed out; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration), GASTROINTESTINAL DISORDER (gastrointestinal symptoms) and PYREXIA (fever of 103 F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SEIZURE (seizure like activity) (seriousness criteria hospitalization and medically significant), NAUSEA (profound wave of nausea, passed out) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out) (seriousness criteria hospitalization and medically significant), DEHYDRATION (dehydration) (seriousness criterion hospitalization) and PYREXIA (fever of 103 F) (seriousness criterion hospitalization). On 25-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (gastrointestinal symptoms) (seriousness criterion hospitalization). The patient was hospitalized on 03-Mar-2021 due to DEHYDRATION, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, NAUSEA, PYREXIA and SEIZURE. At the time of the report, SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration) and GASTROINTESTINAL DISORDER (gastrointestinal symptoms) outcome was unknown and PYREXIA (fever of 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 103 (High) 103 F fever. On 03-Mar-2021, Computerised tomogram head: unknown did not find anything..         Concomitant products were not provided.  At the hospital the patient was treated for dehydration. patient was due for an endoscopy to be performed on 24 Aug 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Seizure
Clinical narrative: gastrointestinal symptoms; fever of 103 F; seizure like activity; profound wave of nausea, passed out; profound wave of nausea, passed out; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration), GASTROINTESTINAL DISORDER (gastrointestinal symptoms) and PYREXIA (fever of 103 F) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SEIZURE (seizure like activity) (seriousness criteria hospitalization and medically significant), NAUSEA (profound wave of nausea, passed out) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out) (seriousness criteria hospitalization and medically significant), DEHYDRATION (dehydration) (seriousness criterion hospitalization) and PYREXIA (fever of 103 F) (seriousness criterion hospitalization). On 25-Jun-2021, the patient experienced GASTROINTESTINAL DISORDER (gastrointestinal symptoms) (seriousness criterion hospitalization). The patient was hospitalized on 03-Mar-2021 due to DEHYDRATION, GASTROINTESTINAL DISORDER, LOSS OF CONSCIOUSNESS, NAUSEA, PYREXIA and SEIZURE. At the time of the report, SEIZURE (seizure like activity), NAUSEA (profound wave of nausea, passed out), LOSS OF CONSCIOUSNESS (profound wave of nausea, passed out), DEHYDRATION (dehydration) and GASTROINTESTINAL DISORDER (gastrointestinal symptoms) outcome was unknown and PYREXIA (fever of 103 F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 103 (High) 103 F fever. On 03-Mar-2021, Computerised tomogram head: unknown did not find anything..         Concomitant products were not provided.  At the hospital the patient was treated for dehydration. patient was due for an endoscopy to be performed on 24 Aug 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) 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.   The patient had returned for receiving the second dose on 13-Aug-2021. The pharmacist reported that the expiration date on the vial was 12/31/69. No concomitant medication information was provided. No treatment medication information were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia, Product temperature excursion issue
Clinical narrative: Foot cramping on and off; Shoulder pain/ Uncomfortable Shoulder; Myalgia on the same side as the vaccine was administered; She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder), MYALGIA (Myalgia on the same side as the vaccine was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder), MYALGIA (Myalgia on the same side as the vaccine was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination). On 12-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination) had resolved. At the time of the report, MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder) and MYALGIA (Myalgia on the same side as the vaccine was 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: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-286793 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling of the armpit; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling of the armpit) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling of the armpit). At the time of the report, SWELLING (Swelling of the armpit) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: Symptoms become more pronounced; Fatigue; After receiving the second dose, he started to have shortness of breath; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (After receiving the second dose, he started to have shortness of breath), CHEST PAIN (Chest pain), CONDITION AGGRAVATED (Symptoms become more pronounced) and FATIGUE (Fatigue) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Vegetable allergy (Eggplant). Concomitant products included TRAZODONE, CLONIDINE and LISINOPRIL for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced DYSPNOEA (After receiving the second dose, he started to have shortness of breath), CHEST PAIN (Chest pain) and FATIGUE (Fatigue). On 09-Aug-2021, the patient experienced CONDITION AGGRAVATED (Symptoms become more pronounced). At the time of the report, DYSPNOEA (After receiving the second dose, he started to have shortness of breath), CHEST PAIN (Chest pain), CONDITION AGGRAVATED (Symptoms become more pronounced) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised; Received booster shots of the Moderna COVID-19 vaccine; Pains/aches; Low grade Fever; Felt Like The Flu; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 037K20 and 0881021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BACLOFEN, SITAGLIPTIN PHOSPHATE (JANUVIA), METFORMIN HYDROCHLORIDE, VITAMIN D NOS, IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]), HYDROXYCHLOROQUINE, CYCLOBENZAPRINE, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), LOSARTAN, CHLORTALIDONE (CHLORTHALIDONE) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt Like The Flu) and PYREXIA (Low grade Fever). 21-Mar-2021, the patient experienced MYALGIA (Pains/aches). On an unknown date, the patient experienced IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) (seriousness criterion medically significant) and EXTRA DOSE ADMINISTERED (Received booster shots of the Moderna COVID-19 vaccine). At the time of the report, IMMUNODEFICIENCY (Received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised) outcome was unknown and INFLUENZA LIKE ILLNESS (Felt Like The Flu), EXTRA DOSE ADMINISTERED (Received booster shots of the Moderna COVID-19 vaccine), MYALGIA (Pains/aches) and PYREXIA (Low grade Fever) had resolved.            No treatment information was provided. The patient mentioned that he had not experienced any side effects from the booster at this point.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information will be requested regarding Immunocompromise onset.   This case was linked to MOD-2021-018907 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information will be requested regarding Immunocompromise onset.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: People have died from 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 DEATH (People have died from the Moderna vaccine) 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 No adverse event (no medical history per source document).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant products were reported. No treatment information provided.  Company comment: This is a case of sudden death in a patient with unknown age and gender and with unknown past medical history who died in unknown days after receiving a dose of the vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a patient with unknown age and gender and with unknown past medical history who died in unknown days after receiving a dose of the vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: People have died from the Moderna vaccine
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported by the reporter.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-286769 (Patient Link).   Reporter did not allow further contact
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatments were provided. HCP has provided demographics for all the patients who received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021). For this patient, the number of days that have passed were 4   This case was linked to MOD-2021-278394 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not receive 2nd dose between day 25-35 of receiving the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 1st dose). On 22-Apr-2021, PRODUCT DOSE OMISSION ISSUE (did not receive 2nd dose between day 25-35 of receiving the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate
Clinical narrative: their heart being slow; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (their heart being slow) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (and their heart and respiratory system became really affected.) and Open heart surgery. Concurrent medical conditions included Cancer.    On 16-Jul-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 CARDIAC DISORDER (their heart being slow). At the time of the report, CARDIAC DISORDER (their heart being slow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: slow (Low) heart being slow.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Patient take a lot of concomitant medications for cancer.  No Concomitant and treatment medications information were not reported.  Company Comment: Very limited information regarding the event has been provided at this time. The patient's medical history of open heart surgery may be a confounding factor to the event. No further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time. The patient's medical history of open heart surgery may be a confounding factor to the event. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Inappropriate schedule of product administration, Muscle tightness
Clinical narrative: foot went number; rings of tightness on leg; Beyond 42 days for 2nd dose; slight headaches on left side of the head; 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 HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) and HEADACHE (slight headaches on left side of the head) 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 HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) and HEADACHE (slight headaches on left side of the head). At the time of the report, HYPOAESTHESIA (foot went number), MUSCLE TIGHTNESS (rings of tightness on leg) and HEADACHE (slight headaches on left side of the head) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Beyond 42 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had got multiple MRI and was advised by doctors to wait on second dose.  No concomitant medications were reported. No treatment medications were reported.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Lymphadenopathy, Muscle discomfort, Myalgia
Clinical narrative: muscle discomfort; general inflammation; lymph system is inflamed/swollen; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Myalgia, Vaginal haemorrhage
Clinical narrative: I haven't had a period since 2018 (hysterectomy)/I came on my period today; bleeding; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (she haven't had a period since 2018) in 2018.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain). At the time of the report, MENSTRUAL DISORDER (I haven't had a period since 2018 (hysterectomy)/I came on my period today), VAGINAL HAEMORRHAGE (bleeding) and MYALGIA (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a vaccine which was more than 30 days in the refrigerator; Received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: accidentally injected expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial). On 14-Aug-2021, EXPIRED PRODUCT ADMINISTERED (accidentally injected expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that the vial still had the same milky looking appearance and no visual changes. The patient did not experience any side effects.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haematochezia
Clinical narrative: Also spotted medium bright  red  blood  in his  urine; Blood and several small dark clots  in his stool and it happened  3  times during the day; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood and several small dark clots  in his stool and it happened  3  times during the day) and BLOOD URINE PRESENT (Also spotted medium bright  red  blood  in his  urine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood and several small dark clots  in his stool and it happened  3  times during the day) (seriousness criterion medically significant). On 12-Aug-2021, the patient experienced BLOOD URINE PRESENT (Also spotted medium bright  red  blood  in his  urine) (seriousness criterion medically significant). The patient was treated with OMEGA-3 FATTY ACIDS ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form; CYANOCOBALAMIN (VITAMIN B-12) ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form and UBIDECARENONE (CO Q-10) ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form. At the time of the report, HAEMATOCHEZIA (Blood and several small dark clots  in his stool and it happened  3  times during the day) and BLOOD URINE PRESENT (Also spotted medium bright  red  blood  in his  urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used included a garlic tablet, supplements to treat the symptoms, unspecified medications for anxiety and pain, two inhalers, a nasal inhaler and an allergy medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Myalgia, Pain
Clinical narrative: received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.; Aches and Pains (first dose); Aches and Pains (first dose); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20 and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.) (seriousness criterion medically significant), PAIN (Aches and Pains (first dose)) and MYALGIA (Aches and Pains (first dose)). At the time of the report, IMMUNODEFICIENCY (received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.), PAIN (Aches and Pains (first dose)) and MYALGIA (Aches and Pains (first dose)) outcome was unknown.            Concomitant medication use was not reported.   Treatment information was not provided.  Booster Dose Information: Lot# -  0881021A Expiration Date -Not available Indication - COVID-19  Patient said that he and his wife both received booster shots of the Moderna COVID-19 vaccine today (14Aug2021) because they are both immunocompromised.  Agent confirmed first dose and side effect information from previous case was correct. Caller confirmed that dose information was the same for he and his wife for all three doses. His wife experienced a few aches and pains with each of the first two doses but is fine so far after the booster dose. The caller mentioned that her second dose produced more severe side effects. It is unsure if the wife is currently on any concomitant medications at this time.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Influenza like illness, Limb discomfort, Myalgia
Clinical narrative: Left her leg was was frozen; Flu-ish; Hot; Slept for 3 days; Body painful; Tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days) and MYALGIA (Body painful) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), MYALGIA (Body painful), FATIGUE (Tired) and NAUSEA (Nausea). At the time of the report, LIMB DISCOMFORT (Left her leg was was frozen) had resolved, INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown and MYALGIA (Body painful) had not resolved.            Concomitant medications were not provided.  The patient could not remember if Tylenol was taken or not.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: Left her leg was was frozen; Flu-ish; Hot; Slept for 3 days; Body painful; Tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days) and MYALGIA (Body painful) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Left her leg was was frozen), INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), MYALGIA (Body painful), FATIGUE (Tired) and NAUSEA (Nausea). At the time of the report, LIMB DISCOMFORT (Left her leg was was frozen) had resolved, INFLUENZA LIKE ILLNESS (Flu-ish), FEELING HOT (Hot), SOMNOLENCE (Slept for 3 days), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown and MYALGIA (Body painful) had not resolved.            Concomitant medications were not provided.  The patient could not remember if Tylenol was taken or not.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart beat from light activities; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat from light activities) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059e21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heart beat from light activities). At the time of the report, HEART RATE INCREASED (fast heart beat from light activities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Is it normal to have site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is it normal to have site pain) 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 SITE PAIN (Is it normal to have site pain). At the time of the report, VACCINATION SITE PAIN (Is it normal to have site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication was provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: red spot at at injection spot; injection site sore and itchy; right arm at injection site swollen; right arm at injection site sore; covid arm; good size patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot) and VACCINATION SITE SWELLING (right arm at injection site swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (injection site sore and itchy). On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at at injection spot). In August 2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore). At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received contains. New event of injection site sore was added. Coding was corrected for the events injection site itching and redness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red spot at at injection spot; injection site sore and itchy; right arm at injection site swollen; right arm at injection site sore; covid arm; good size patch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot) and VACCINATION SITE SWELLING (right arm at injection site swollen) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (injection site sore and itchy). On 10-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at at injection spot). In August 2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore). At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE REACTION (good size patch at injection site), VACCINATION SITE PRURITUS (injection site sore and itchy), VACCINATION SITE ERYTHEMA (red spot at at injection spot), VACCINATION SITE SWELLING (right arm at injection site swollen) and VACCINATION SITE PAIN (right arm at injection site sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received contains. New event of injection site sore was added. Coding was corrected for the events injection site itching and redness
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: who received "expired" vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-278394 (Patient Link).
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: who received "expired" vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (who received "expired" vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.   Reporter did not allow further contact