chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered dose form a vial punctured more than 12hs before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) 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 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter had stated that the vial was opened on 16 SEP 2021 and was administered on 21 Sep 2021, which was 5 days past the limit and was given to 2 patients.  Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue
Clinical narrative: Patient  didn't get the second dose; lymph nodes swelled all over his body; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelled all over his body) and PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced LYMPHADENOPATHY (lymph nodes swelled all over his body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose). At the time of the report, LYMPHADENOPATHY (lymph nodes swelled all over his body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient  didn't get the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Hypersomnia
Clinical narrative: weakness; dizzy; Sleeping constantly, not even waking up to eat; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (autoimmune condition).   On 15-Sep-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 ASTHENIA (weakness), DIZZINESS (dizzy), HYPERSOMNIA (Sleeping constantly, not even waking up to eat) and CHILLS (chills). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizzy) and CHILLS (chills) had not resolved and HYPERSOMNIA (Sleeping constantly, not even waking up to eat) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This case concerns a 76-year-old, female patient with medical history of an autoimmune condition, who experienced the unexpected non-serious adverse event of special interest of hypersomnia and other non-serious adverse events. The event occurred on unknown date after the third dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the event occurred after the third dose of vaccine and no additional dosing will be given. The medical history of an autoimmune condition could be a potential confounder for the event. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Swelling
Clinical narrative: Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not; The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days) and DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     The patient's past medical history included Aortic dissection in 2012 and Splenectomy.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days). On an unknown date, the patient experienced DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not). The patient was treated with IBUPROFEN for Neck swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (The right side of her neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31AUG2021 and after two days) was resolving and DYSPHAGIA (Still does not feel right, like when she swallows/Touch or swallow feels different like she has a lump in her throat but she does not) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  On 31-Aug-2021, The right side of neck swelled up the size of two baseballs. It would get smaller then get bigger for two days ever since 31-Aug-2021 and after two days, the swelling went down, and it stopped doing that. Since then the right side of her neck has not been the same. it looks good, but it still did not feel right, like when she swallows. She could touch the left side it feels fine, but the right side does not feel fine. She did not think she would be getting her second vaccine due to the swelling of her neck. Touch or swallow felts different like she has a lump in her throat but she did not.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist stated that 3 doses of the Moderna COVID-19 vaccine drawn in syringes were administered to patients on 22SEPT2021. The doses were beyond the 12-hours recommended by Moderna. Concomitant medications were not provided. Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Chills, Fatigue, Headache
Clinical narrative: Chest pain; Headache; Body ache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.   On 20-Sep-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 20-Sep-2021, the patient experienced CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Blood pressure measurement: 130/90 (High) 130/90.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-328763 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Chest pain; Headache; Body ache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.   On 20-Sep-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 20-Sep-2021, the patient experienced CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (Fatigue). On 22-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), HEADACHE (Headache), MYALGIA (Body ache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Blood pressure measurement: 130/90 (High) 130/90.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-328763 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccine used; incorrect product storage; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (incorrect product storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.The vial was suppose to be wasted since it was set to expire after the 12 hour mark at 10:30PM 17-Sep-2021 (Friday). However, no one was available to throw it in the waste. Accidentally, yesterday, 21-Sept-2021, a Medical Assistant drew up the expired dose and gave it to one of their providers.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo; dizziness; 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 VERTIGO (vertigo) and DIZZINESS (dizziness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization) and DIZZINESS (dizziness) (seriousness criterion hospitalization). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) outcome was unknown.      No concomitant and treatment information were reported by the reporter.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected  serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected  serious events of Vertigo and Dizziness. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain/it hurt a lot more than the first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain/it hurt a lot more than the first one) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 VACCINATION SITE PAIN (Injection site pain/it hurt a lot more than the first one). At the time of the report, VACCINATION SITE PAIN (Injection site pain/it hurt a lot more than the first one) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-328742 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given past the 12 hour post puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-328946, MOD-2021-328010 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No treatment drug was reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). In August 2021, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned. Patient stated that he experienced the events after 12 hours of vaccinations and lasted for about 36 hours.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Extra dose administered, Lip swelling, Social problem
Clinical narrative: affecting my social life; it is worse today/not life threatening; upper lip is swollen; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening), SOCIAL PROBLEM (affecting my social life) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 023M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Dermatological filler called "Restylane Silk" in upper lip.).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced LIP SWELLING (upper lip is swollen) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 22-Sep-2021, the patient experienced CONDITION AGGRAVATED (it is worse today/not life threatening). On an unknown date, the patient experienced SOCIAL PROBLEM (affecting my social life). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 21-Sep-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, LIP SWELLING (upper lip is swollen), CONDITION AGGRAVATED (it is worse today/not life threatening) and SOCIAL PROBLEM (affecting my social life) had not resolved.            Concomitant drug was not reported.  It was reported that patient received 3rd dose of vaccine as suggested by her physician due to age. It was advised by dermatologist to take Motrin as treatment drug to the patient.Consumer does not have Motrin and is taking Aleve. Consumer states she has no problems to 1st and 2nd dose of the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: my heart hurt so bad/terrible pain in my heart; I thought I was gonna die; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) and METFORMIN for an unknown indication.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die). At the time of the report, CHEST PAIN (my heart hurt so bad/terrible pain in my heart) and FEELING ABNORMAL (I thought I was gonna die) outcome was unknown.            No treatment medications were reported.  Concomitant medication includes: Thyroid pill
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), ILLNESS (has been sick since then/kind a little sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats) and INCOHERENT (incoherent) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Blood pressure high. On 17-Sep-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 18-Sep-2021, the patient experienced MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats), NAUSEA (nauseous) and MYALGIA (body aches). On 20-Sep-2021, the patient experienced ILLNESS (has been sick since then/kind a little sick). On 22-Sep-2021, the patient experienced INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills). At the time of the report, MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown and ILLNESS (has been sick since then/kind a little sick), HYPERHIDROSIS (sweats), INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: abnormal (abnormal) 96F but could be wrong. No Treatment medications were reported. Patient went to the urgent care, they performed a COVID test, whose results is still pending.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Incoherent, Malaise, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), ILLNESS (has been sick since then/kind a little sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats) and INCOHERENT (incoherent) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Blood pressure high. On 17-Sep-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 18-Sep-2021, the patient experienced MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats), NAUSEA (nauseous) and MYALGIA (body aches). On 20-Sep-2021, the patient experienced ILLNESS (has been sick since then/kind a little sick). On 22-Sep-2021, the patient experienced INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills). At the time of the report, MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown and ILLNESS (has been sick since then/kind a little sick), HYPERHIDROSIS (sweats), INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: abnormal (abnormal) 96F but could be wrong. No Treatment medications were reported. Patient went to the urgent care, they performed a COVID test, whose results is still pending.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), ILLNESS (has been sick since then/kind a little sick), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats) and INCOHERENT (incoherent) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) for Blood pressure high. On 17-Sep-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 18-Sep-2021, the patient experienced MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), HYPERHIDROSIS (sweats), NAUSEA (nauseous) and MYALGIA (body aches). On 20-Sep-2021, the patient experienced ILLNESS (has been sick since then/kind a little sick). On 22-Sep-2021, the patient experienced INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills). At the time of the report, MALAISE (didn't feel good), FEELING OF BODY TEMPERATURE CHANGE (hot and cold), NAUSEA (nauseous) and MYALGIA (body aches) outcome was unknown and ILLNESS (has been sick since then/kind a little sick), HYPERHIDROSIS (sweats), INCOHERENT (incoherent), DIARRHOEA (has diarrhea), VOMITING (throwing up/was spitting on the floor with throw up while on the toilet) and CHILLS (chills) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2021, Body temperature: abnormal (abnormal) 96F but could be wrong. No Treatment medications were reported. Patient went to the urgent care, they performed a COVID test, whose results is still pending.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vial punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not provided.  The patient received dose of Moderna vaccine (unknown if it is first or second dose) from a vial which was punctured for more than 12 hours.The pharmacist said the vial was punctured on Monday 20 -Sep-2021 at 12 pm, they left it in the fridge and would have expired by 12 AM on Tuesday 21-Sep-2021. It was administered then at 3.59 PM, 4.53 PM, 9.15 PM and 9.16 PM.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 13, 2021, patient experienced inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose). On Sep 21, 2021, inappropriate schedule of product administration (2nd dose administered 5 weeks, 4 days after 1st dose) resolved. No concomitant medication or treatment information reported. This case linked to MOD-2021-329095 (patient link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm after the first vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (experienced a sore arm after the first vaccination). At the time of the report, PAIN IN EXTREMITY (experienced a sore arm after the first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-328621.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       A friend was going through similar symptoms as the caller. No concomitant medication was reported.  No treatment medication use was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given expired vaccine; 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 (Given expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose had been administered outside of the 12 hour puncture viability window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose had been administered outside of the 12 hour puncture viability window) 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.   No concomitant medication information provided by the reporter. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document received contains Dose details of suspect drug were added
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered after 12-hours in syringes; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm; a little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-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 PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills). At the time of the report, PAIN IN EXTREMITY (sore arm) and CHILLS (a little bit of chills) outcome was unknown.            Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328976 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients given vaccine later than 12 hours after puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given vaccine later than 12 hours after puncture) 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.   No concomitant medication was reported. No treatment was treatment.   This case was linked to MOD-2021-328674, MOD-2021-327879 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for COVID-19) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced COVID-19 (I tested positive for COVID-19). At the time of the report, COVID-19 (I tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported. The patient tested positive for Covid-19, and reported that his daughter caught it from school, and the patient caught it from her.; Sender's Comments: This case concerns a 46-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately four and a half months after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the second dose was disclosed. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: sore right arm; headache; a little bit of nausea; loose bowel movement, very sudden; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, High cholesterol and Blood pressure high.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (loose bowel movement, very sudden). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea). At the time of the report, DIARRHOEA (loose bowel movement, very sudden), PAIN IN EXTREMITY (sore right arm), HEADACHE (headache) and NAUSEA (a little bit of nausea) outcome was unknown.            Concomitant medication of the patient included medication for osteoporosis, medication for high cholesterol and medication for high blood pressure.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-328939 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: discoloration on both forearms up to shoulders/dark patch; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 002F2119) 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 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch). At the time of the report, SKIN DISCOLOURATION (discoloration on both forearms up to shoulders/dark patch) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   No Concomitant medication was reported.  No treatment Drug was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were administered after 12-hours in syringes; Doses were administered after 12-hours in syringes; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 12-hours in syringes) and PRODUCT STORAGE ERROR (Doses were administered after 12-hours in syringes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was reported No Concomitant medication was reported.   This case was linked to MOD-2021-329029 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Product dose omission issue
Clinical narrative: Palpitations; felt tingle all over; did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0700C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), PARAESTHESIA (felt tingle all over) and PRODUCT DOSE OMISSION ISSUE (did not get the second dose). At the time of the report, PALPITATIONS (Palpitations) and PARAESTHESIA (felt tingle all over) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication was not reported. Treatment information was not reported.