chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Diarrhea; feel off, strange / feeling not myself; Nausea; sore  arm,; fatigue; mild headache / dull headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself), MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Multivitamin.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Aug-2021, MYALGIA (sore  arm,) and FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea) outcome was unknown and HEADACHE (mild headache / dull headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he  went  to his  doctor and  they advised him to take Ibuprofen and drink fluid. Patient took Tylenol but  it did not help that much, and  patient is  only  Multivitamin as  his regular medication.; 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 15-year-old patient received the 1st dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 15-year-old patient received the 1st dose of the Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 15-year-old patient received the 1st dose of the Moderna vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 15-year-old patient received the 1st dose of the Moderna vaccine) 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.   There were no side effects after vaccine administration. Patient was aware of the situation. No concomitant medications were reported. No treatment related information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of cardiac disorder (I'm going in for a pace maker surgery tomorrow) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cardiac disorder (I'm going in for a pace maker surgery tomorrow). At the time of the report, cardiac disorder (I'm going in for a pace maker surgery tomorrow) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication, lab data or treatment information reported.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4) in a 51-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) (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 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine which was more than 30 days in the refrigerator / the number of days that have passed were 4) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given. Other event included updated patient information.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Inflammation, Mobility decreased
Clinical narrative: Exacerbation of arthritis spread everywhere in body; Hands in so much pain she cannot bend them; inflammatory response; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis since 2016, Lyme disease and Rheumatoid arthritis since 2016. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response). At the time of the report, ARTHRITIS (Exacerbation of arthritis spread everywhere in body), MOBILITY DECREASED (Hands in so much pain she cannot bend them) and INFLAMMATION (inflammatory response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient lab data include blood work. Patient second dose on 22-Apr-2021 was provided. No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Nausea
Clinical narrative: difficulty of breathing after first dose; he's been having insomnia.; felt nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty of breathing after first dose), INSOMNIA (he's been having insomnia.) and NAUSEA (felt nauseous) 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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced DYSPNOEA (difficulty of breathing after first dose), INSOMNIA (he's been having insomnia.) and NAUSEA (felt nauseous). At the time of the report, DYSPNOEA (difficulty of breathing after first dose), INSOMNIA (he's been having insomnia.) and NAUSEA (felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 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 Route), the reporter did not provide any causality assessments.   No treatment and concomitant information was reported.   Reporter did not allow further contact
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: all the patients who received a vaccine which was more than 30 days in the refrigerator; all the patients who 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 (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 44-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 29-Jul-2021, 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 (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (all the patients who received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) 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.   Treatment and concomitant drug was not reported.  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 26.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 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) in a 61-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 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Vaccines were stored more than 30 days in refrigerator, 30th day was on 03-Jul-2021
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 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 (30 days were on 03Jul2021)) in a 46-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11) 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 EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)/number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in arm hurts) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (pain in arm hurts). At the time of the report, pain in extremity (pain in arm hurts) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (experienced side effects) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. August 2021, patient experienced vaccination complication (experienced side effects). At the time of the report, vaccination complication (experienced side effects) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Can the moderna vaccine cause diarrhea?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Can the moderna vaccine cause diarrhea?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Can the moderna vaccine cause diarrhea?). At the time of the report, DIARRHOEA (Can the moderna vaccine cause diarrhea?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: pain in the arm; injection site itchy; injection site swollen; feels warm in the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feels warm in the injection site), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (injection site swollen) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced VACCINATION SITE WARMTH (feels warm in the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 15-Aug-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, VACCINATION SITE WARMTH (feels warm in the injection site), PAIN IN EXTREMITY (pain in the arm), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (injection site swollen) 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Herpes zoster, Malaise
Clinical narrative: Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .; She feels sick & doesn't feel right; Feeling not the same person as she was; Stomach issue; Other side effects; Rash,a few on her back,a band with little dots on the chest,a few on her back; She still has bad headache; She still has bad headache and is kind of nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue) and VACCINATION COMPLICATION (Other side effects) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038AZ1A and 019M20A/ 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox. Previously administered products included for an unreported indication: FLU. Concomitant products included DICLOFENAC for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .) had not resolved and MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous) outcome was unknown.            This case was linked to MOD-2021-288308 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Vaccination complication
Clinical narrative: Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .; She feels sick & doesn't feel right; Feeling not the same person as she was; Stomach issue; Other side effects; Rash,a few on her back,a band with little dots on the chest,a few on her back; She still has bad headache; She still has bad headache and is kind of nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue) and VACCINATION COMPLICATION (Other side effects) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038AZ1A and 019M20A/ 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox. Previously administered products included for an unreported indication: FLU. Concomitant products included DICLOFENAC for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .), MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingle,Shingle is still on her chest and in her body,other symptoms related to the shingle and thinks might have internal shingle .) had not resolved and MALAISE (She feels sick & doesn't feel right), FEELING ABNORMAL (Feeling not the same person as she was), ABDOMINAL DISCOMFORT (Stomach issue), VACCINATION COMPLICATION (Other side effects), RASH (Rash,a few on her back,a band with little dots on the chest,a few on her back), HEADACHE (She still has bad headache) and NAUSEA (She still has bad headache and is kind of nauseous) outcome was unknown.            This case was linked to MOD-2021-288308 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: I woke up without a voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (I woke up without a voice) 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 APHONIA (I woke up without a voice). At the time of the report, APHONIA (I woke up without a voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Vaccinated months ago and now they have diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Vaccinated months ago and now they have diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 013M20A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 DIARRHOEA (Vaccinated months ago and now they have diarrhea). At the time of the report, DIARRHOEA (Vaccinated months ago and now they have diarrhea) outcome was unknown. No treatment information was provided. The patient enquired about the booster dose. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  It is unclear how long after previous administration of the vaccine the diarrhea occurred and whether it is associated with the vaccine.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.  It is unclear how long after previous administration of the vaccine the diarrhea occurred and whether it is associated with the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: legs swelled a lot; pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs; couldn't move her ankles; hard to move them; sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened). At the time of the report, PERIPHERAL SWELLING (legs swelled a lot), PAIN IN EXTREMITY (pain in the legs\, the pain is too strong. Pain is in both legs but principally in one of the legs), JOINT STIFFNESS (couldn't move her ankles), MOBILITY DECREASED (hard to move them) and PAIN (sthe pain is too strong / pain is unbelievable / till having this problem, it has worsened) outcome was unknown.            Concomitant medication not provided by reporter. Patient went to the emergency room twice and the doctor did not seem to understand the issue. Treatment information not provided by reporter. The Patient states the pain is strong that the patient is trying to look for an alternative,  .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Tinnitus
Clinical narrative: Ringing in her ears; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears). On 21-Aug-2021, MYALGIA (sore arm), HEADACHE (headache) and TINNITUS (ringing in her ears) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.; vaccine greater than 12 hours in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow Up information was received on 03-Sep-2021 and contains No new information. On 06-Sep-2021: Follow up received on 06-SEP-2021 and contains no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine greater than 12 hours in refrigerator; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-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 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   1 punctured vial of Moderna COVID-19 vaccine, which was first opened on 23-AUG-2021 around 8-10AM, in the refrigerator for more than 12 hours. On 24-AUG-2021, They Injected the expired Moderna COVID-19 vaccine to 7 patients between 8AM -11:30AM.  No concomitant medication was provided.  No treatment medications was provided.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient received 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose) had resolved.            Concomitant product was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up information received and contains no new information On 10-Sep-2021: Non-significant follow up appended. Contains no new information. Added contact details for reporter as it was not captured in previous version. On 11-Oct-2021: Non-Significant follow up received contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame; 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 EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame) 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 EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The vial had been stored in the refrigerator since then. For 2 patients, it was the 2nd dose. For 1 patient, it was the 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Tired/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired/exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676, 028a21a and 012a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received third 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Tired/exhaustion). At the time of the report, PYREXIA (Fever) and FATIGUE (Tired/exhaustion) outcome was unknown.            No Concomitant informations were reported. No Treatment informations were reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia, Feeding disorder, Parosmia, Vomiting
Clinical narrative: everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting; all food taste like chemical; if the patient try to swallow it  feels like gagging and vomiting instantly; has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months; feels like gagging and vomiting instantly; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly). At the time of the report, PAROSMIA (everything the patient eats, including meat , chicken, hamburger, French fries,  smell wrong, nasty and disgusting), DYSGEUSIA (all food taste like chemical), DYSPHAGIA (if the patient try to swallow it  feels like gagging and vomiting instantly), FEEDING DISORDER (has not been able to eat and drink except sugar, potatoes, lemonade and water since last 4 months) and VOMITING (feels like gagging and vomiting instantly) outcome was unknown.            Concomitant medications were not provided by the reporter Treatment information was not provided. The patient mentioned that salad and lettuce tasted like dirt and all drinks, including coffee, grape fruit juice tasted like an acid. The physician recommended the patient to drink water and lemonade.   This case was linked to MOD-2021-296659 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of suspected COVID-19 (symptoms of COVID-19) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On Aug 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Aug 22, 2021, patient experienced COVID-19 (symptoms of COVID-19). At the time of the report, COVID-19 (symptoms of COVID-19) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Patient thinks they already had COVID-19 since August. No concomitant medication or treatment information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Cough, Influenza like illness, Myalgia, Nausea
Clinical narrative: Very bad nausea; Very bad vomiting; Bad dry cough; Body aches,Sore arm; Fever; Flu-like symptoms; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), COUGH (Bad dry cough), NAUSEA (Very bad nausea) and MYALGIA (Body aches,Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included vitamins and GABAPENTIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever). In June 2021, the patient experienced COUGH (Bad dry cough). On an unknown date, the patient experienced NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting). On 10-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad dry cough) outcome was unknown and NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting) had resolved.            The patient treatment information include The first time the patient was given a Z-pack and a steroid shot. The second time the provider prescribed steroid pills, codeine cough syrup, pills to suppress a cough, and omeprazole for possible heart burn. During the last visit the provider gave a steroid shot to the patient and a very strong antibiotic, which the patient thinks was azithromycin.   This case was linked to MOD-2021-297574 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Very bad nausea; Very bad vomiting; Bad dry cough; Body aches,Sore arm; Fever; Flu-like symptoms; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), COUGH (Bad dry cough), NAUSEA (Very bad nausea) and MYALGIA (Body aches,Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included vitamins and GABAPENTIN for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever). In June 2021, the patient experienced COUGH (Bad dry cough). On an unknown date, the patient experienced NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting). On 10-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), BEDRIDDEN (Couldn't get out of bed), MYALGIA (Body aches,Sore arm) and PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad dry cough) outcome was unknown and NAUSEA (Very bad nausea) and VOMITING (Very bad vomiting) had resolved.            The patient treatment information include The first time the patient was given a Z-pack and a steroid shot. The second time the provider prescribed steroid pills, codeine cough syrup, pills to suppress a cough, and omeprazole for possible heart burn. During the last visit the provider gave a steroid shot to the patient and a very strong antibiotic, which the patient thinks was azithromycin.   This case was linked to MOD-2021-297574 (Patient Link).