chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Generalised tonic-clonic seizure, Somnolence
Clinical narrative: He had a grand mal seizure; was sleepy; Didn't eat; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy and Lennox-Gastaut syndrome (Diagnosed with a severe form of LGS). Concurrent medical conditions included Speech disorder (He's nonverbal).   On 10-Nov-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure) (seriousness criterion medically significant), SOMNOLENCE (was sleepy) and DECREASED APPETITE (Didn't eat). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure), SOMNOLENCE (was sleepy) and DECREASED APPETITE (Didn't eat) outcome was unknown.     No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment - This case concerns a 30-year-old, male patient with medical history of Lennox-Gestaut syndrome and epilepsy, who experienced the unexpected events of generalised tonic-clonic seizure, somnolence and decreased appetite. The events occurred on the same day day after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, male patient with medical history of Lennox-Gestaut syndrome and epilepsy, who experienced the unexpected events of generalised tonic-clonic seizure, somnolence and decreased appetite. The events occurred on the same day day after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (blood pressure that is controlled.). Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter.   This case was linked to MOD-2021-384436 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Residences who received Moderna vaccine contracted COVID-19; 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 COVID-19 (Residences who received Moderna vaccine contracted COVID-19) 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 COVID-19 (Residences who received Moderna vaccine contracted COVID-19). At the time of the report, COVID-19 (Residences who received Moderna vaccine contracted COVID-19) 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.   Concomitant medications were not reported. Treatment details were not provided. This is spontaneous case concerning patients with unknown medical history, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred after an unknown dose number of mRNA 1273. Reporter states that a group of nursing home facility residents were diagnosed with COVID 19 after being vaccinated. This case has no identifiers or valid patient for all standards, and so, invalid.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is spontaneous case concerning patients with unknown medical history, who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred after an unknown dose number of mRNA 1273. Reporter states that a group of nursing home facility residents were diagnosed with COVID 19 after being vaccinated. This case has no identifiers or valid patient for all standards, and so, invalid.   The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Malaise, Pain in extremity, Tinnitus
Clinical narrative: Ringing in my ears; Had a little bit of feeling under the weather; Sore arm for 1 day; I have acute hearing loss. My hearing is down to about 80 percent; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Ringing in my ears), HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent), MALAISE (Had a little bit of feeling under the weather) and PAIN IN EXTREMITY (Sore arm for 1 day) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced MALAISE (Had a little bit of feeling under the weather) and PAIN IN EXTREMITY (Sore arm for 1 day). On 03-Nov-2021, the patient experienced TINNITUS (Ringing in my ears). In November 2021, the patient experienced HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, PAIN IN EXTREMITY (Sore arm for 1 day) had resolved. At the time of the report, TINNITUS (Ringing in my ears) had not resolved and HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent) and MALAISE (Had a little bit of feeling under the weather) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 03-Nov-202, day three, patient had ringing in ears and it progressively got worse. On 10-Nov-2021, patient went to urgent care. They gave a cortisone shot (solumedrol) and a prescription for prednisone. Patient had acute hearing loss. His hearing was down to about 80 percent.   This case was linked to MOD-2021-385149, MOD-2021-385158 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: general malaise; sore arm; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm). At the time of the report, MALAISE (general malaise) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-385128, MOD-2021-385158 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: sore arm; general malaise; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise). At the time of the report, PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-385149 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Can hardly walk; Having left ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain). At the time of the report, GAIT DISTURBANCE (Can hardly walk) and ARTHRALGIA (Having left ankle pain) outcome was unknown.            No concomitant and medication information provided.  No treatment information provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: After first shot my knee went down hill; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (After first shot my knee went down hill) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (Underwent left knee surgery (torn meniscus)) in November 2020, Back surgery, Neck surgery, Hand operation, Wrist surgery, Toe operation (Underwent right toe surgery), Ankle operation and Surgery (Underwent left thumb surgery). Concurrent medical conditions included Chronic pain (Had chronic pain all over his body from the past surgeries) and Hypothyroidism (Low Thyroid Level). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, PARACETAMOL (TYLENOL [PARACETAMOL]) and IBUPROFEN for an unknown indication.    On 01-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 ARTHROPATHY (After first shot my knee went down hill). At the time of the report, ARTHROPATHY (After first shot my knee went down hill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported  This case concerns a 61-year-old, male patient, with medical history of knee surgery, who experienced the non-serious, unexpected event of arthropathy. The event occurred  on unspecified date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of event is unknown. The patient's history of knee surgery remains a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-374096 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient, with medical history of knee surgery, who experienced the non-serious, unexpected event of arthropathy. The event occurred  on unspecified date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of event is unknown. The patient's history of knee surgery remains a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: First dose received on 4March2021, Second dose received on 21April2021; she still has soreness in her arm from April./The soreness is in the same arm where she received the injections; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027AZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections). On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021). On 21-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 4March2021, Second dose received on 21April2021) had resolved. At the time of the report, INJECTION SITE PAIN (she still has soreness in her arm from April./The soreness is in the same arm where she received the injections) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Feeling abnormal, Headache, Migraine
Clinical narrative: Like a severe migraine; Achy; Miserable; Was in bed for 3 days; Throwing up; Had a fever; Chills; headache across her forehead was so severe; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days) and VOMITING (Throwing up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus systemic (Lupus mostly in joints and skin).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Nausea, at an unspecified dose and frequency and TRAMADOL for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea) outcome was unknown and BEDRIDDEN (Was in bed for 3 days) had resolved.            No relevant concomitant medications were reported. Treatment includes some pills for nausea
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Like a severe migraine; Achy; Miserable; Was in bed for 3 days; Throwing up; Had a fever; Chills; headache across her forehead was so severe; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days) and VOMITING (Throwing up) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus erythematosus systemic (Lupus mostly in joints and skin).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), BEDRIDDEN (Was in bed for 3 days), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Nausea, at an unspecified dose and frequency and TRAMADOL for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Like a severe migraine), PAIN (Achy), FEELING ABNORMAL (Miserable), VOMITING (Throwing up), PYREXIA (Had a fever), CHILLS (Chills), HEADACHE (headache across her forehead was so severe) and NAUSEA (Nausea) outcome was unknown and BEDRIDDEN (Was in bed for 3 days) had resolved.            No relevant concomitant medications were reported. Treatment includes some pills for nausea
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Dehydration, Thirst decreased
Clinical narrative: started having bladder infections; she is dehydrated, she is not drinking enough; noticed she wasn't as thirsty as usual; This spontaneous case was reported by a consumer and describes the occurrence of THIRST DECREASED (noticed she wasn't as thirsty as usual), CYSTITIS (started having bladder infections) and DEHYDRATION (she is dehydrated, she is not drinking enough) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LISINOPRIL for Diabetes, PIOGLITAZONE HYDROCHLORIDE (ACTOS) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced THIRST DECREASED (noticed she wasn't as thirsty as usual). In July 2021, the patient experienced CYSTITIS (started having bladder infections) and DEHYDRATION (she is dehydrated, she is not drinking enough). The patient was treated with CEFUROXIME AXETIL (CEFTIN [CEFUROXIME AXETIL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, THIRST DECREASED (noticed she wasn't as thirsty as usual), CYSTITIS (started having bladder infections) and DEHYDRATION (she is dehydrated, she is not drinking enough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included steroid shot occasionally for joints, Tylenol for chronic eye pain.   This case was linked to MOD-2021-385802 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Head injury, Myalgia
Clinical narrative: but her dizziness is terrible/she'd rather be dizzy than get covid; she states that now she is dizzier and her eye watch stated her walking is so unsteady and she is at fall risk/she can tell she is like that all by her self.; head injuries; and her arm was awfully sore for a couple days but now is ok; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (but her dizziness is terrible/she'd rather be dizzy than get covid), GAIT DISTURBANCE (she states that now she is dizzier and her eye watch stated her walking is so unsteady and she is at fall risk/she can tell she is like that all by her self.), HEAD INJURY (head injuries) and MYALGIA (and her arm was awfully sore for a couple days but now is ok) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C210) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    The patient's past medical history included Drug allergy.   On 09-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) at an unspecified dose. On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (but her dizziness is terrible/she'd rather be dizzy than get covid), GAIT DISTURBANCE (she states that now she is dizzier and her eye watch stated her walking is so unsteady and she is at fall risk/she can tell she is like that all by her self.), HEAD INJURY (head injuries) and MYALGIA (and her arm was awfully sore for a couple days but now is ok). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (but her dizziness is terrible/she'd rather be dizzy than get covid), GAIT DISTURBANCE (she states that now she is dizzier and her eye watch stated her walking is so unsteady and she is at fall risk/she can tell she is like that all by her self.) and HEAD INJURY (head injuries) outcome was unknown and MYALGIA (and her arm was awfully sore for a couple days but now is ok) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them; 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 (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (15 total doses were administered/ the vials expired on 10OCT2021/ the vials had already expired when they received them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. All the vials were from the same lot number, the lot number is 006C21A. No break in cold chain supply had occurred. The vials expired on 10 Oct 2021. Thirteen of those doses were first doses in the primary series and two were second doses in the primary series.  No booster doses were administered.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up received includes No New information. On 12-Nov-2021: Follow-up received include updated Number of patients , Details about vaccine expiration.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION COMPLICATION (COVID arm). At the time of the report, VACCINATION COMPLICATION (COVID arm) outcome was unknown.            No concomitant medication was given by reporter. No treatment medication was given by reporter.  Patient had side effects after the Moderna booster shot. It was nothing that needs to go to hospital, nothing dangerous and was just a COVID arm. The patient did not have side effects after the first and second dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain, Vaccination site pain
Clinical narrative: achiness; severe dizziness; arm soreness; tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, 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 experienced PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness). At the time of the report, PAIN (achiness), DIZZINESS (severe dizziness), VACCINATION SITE PAIN (arm soreness) and FATIGUE (tiredness) had not 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient had the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had the COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 COVID-19 (Patient had the COVID). At the time of the report, COVID-19 (Patient had the COVID) outcome was unknown.            Concomitant medications and treatment information were not provided.  Patient was scheduled for booster, but canceled because of COVID. Patient want to reschedule booster.; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: achy; feeling feverish; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills). At the time of the report, PAIN (achy), PYREXIA (feeling feverish) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness of the injection site; Swelling of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 002D21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, 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 experienced VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. Not used anything to alleviate the symptoms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cough, Dyspnoea, Fatigue, Insomnia
Clinical narrative: coughs a lot; can't sleep; short of breath; Anxiety; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughs a lot), INSOMNIA (can't sleep), DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-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 COUGH (coughs a lot), INSOMNIA (can't sleep), DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion). At the time of the report, COUGH (coughs a lot) and INSOMNIA (can't sleep) had not resolved and DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  It was reported that the patient felt exhaustion, like he was short of breath and since 3 days ago he had felt again like that, like he would choke and patient does not had any history of previous heart conditions or myocarditis/pericarditis.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to COCONUT).   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) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   At the time of initial report, the pharmacist was not aware if the patient was experiencing symptoms or taking any prescription medications. The dose was administered more than 12 hours post puncture.  On 10-Nov-2021 the vial was stored in the refrigerator. Number of doses vials: 1 dose 1 vial, punctured 6 times prior On 11-nov-2021 at 10:00 am vial was first punctured and after that it was stored at room temperature and the vail doesn't  undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) 24 hours It was reported that patient was given 0.25 ml from a moderna bottle that had been punctured the day before and had sat on the counter for 24 hours.  No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up was received and updated the patient demographic details, added the medical history, and updated the booster dosage information and added the description of the events in the I-narrative
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Poor quality sleep, Vaccination site pain
Clinical narrative: Inappropriate schedule of vaccine administered; did not sleep good; pain pain/severe pain/so much pain/pain in shoulder; shoulder where got the injection; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (did not sleep good), ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder), VACCINATION SITE PAIN (shoulder where got the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced POOR QUALITY SLEEP (did not sleep good), ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder), VACCINATION SITE PAIN (shoulder where got the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, POOR QUALITY SLEEP (did not sleep good) outcome was unknown and ARTHRALGIA (pain pain/severe pain/so much pain/pain in shoulder) and VACCINATION SITE PAIN (shoulder where got the injection) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.  The patient received primary series from Pfizer COVID19 Vaccine on 20Mar2021 and 20Apr2021. He had no problem with them.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination was given to several members after the expiration date; 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 (Vaccination was given to several members after the expiration date) 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 (Vaccination was given to several members after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccination was given to several members after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.            Patient stated that she increased the ibuprofen dosage.   This case was linked to MOD-2021-385800, MOD-2021-385823 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Contusion, Fall, Feeling of body temperature change
Clinical narrative: contusion on side of head/had bruises/contusions; swelling from the fall; legs gave out from under me; cuts; hitting her head on the concrete/ fall; feeling cold and hot; chills; running a temperature/fever; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (contusion on side of head/had bruises/contusions), SWELLING (swelling from the fall), GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling cold and hot), CHILLS (chills) and PYREXIA (running a temperature/fever). On 04-Nov-2021, the patient experienced CONTUSION (contusion on side of head/had bruises/contusions), SWELLING (swelling from the fall), GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall). On 04-Nov-2021, FEELING OF BODY TEMPERATURE CHANGE (feeling cold and hot), CHILLS (chills) and PYREXIA (running a temperature/fever) had resolved. At the time of the report, CONTUSION (contusion on side of head/had bruises/contusions) and SWELLING (swelling from the fall) had not resolved and GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: high (High) running a temperature.         Treatment details include increase in the Ibuprofen dosage   This case was linked to MOD-2021-385822, MOD-2021-385800 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pyrexia, Swelling, Wound
Clinical narrative: contusion on side of head/had bruises/contusions; swelling from the fall; legs gave out from under me; cuts; hitting her head on the concrete/ fall; feeling cold and hot; chills; running a temperature/fever; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (contusion on side of head/had bruises/contusions), SWELLING (swelling from the fall), GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and IBUPROFEN for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling cold and hot), CHILLS (chills) and PYREXIA (running a temperature/fever). On 04-Nov-2021, the patient experienced CONTUSION (contusion on side of head/had bruises/contusions), SWELLING (swelling from the fall), GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall). On 04-Nov-2021, FEELING OF BODY TEMPERATURE CHANGE (feeling cold and hot), CHILLS (chills) and PYREXIA (running a temperature/fever) had resolved. At the time of the report, CONTUSION (contusion on side of head/had bruises/contusions) and SWELLING (swelling from the fall) had not resolved and GAIT DISTURBANCE (legs gave out from under me), WOUND (cuts) and FALL (hitting her head on the concrete/ fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: high (High) running a temperature.         Treatment details include increase in the Ibuprofen dosage   This case was linked to MOD-2021-385822, MOD-2021-385800 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She was dizzy 4 days later; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (She was dizzy 4 days later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (She was dizzy 4 days later). At the time of the report, DIZZINESS (She was dizzy 4 days later) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported. The patient experienced dizzy  a very normal aftermath of the booster.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: urticaria; after four days rashes all over body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (urticaria) and RASH (after four days rashes all over body) 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 URTICARIA (urticaria) and RASH (after four days rashes all over body). At the time of the report, URTICARIA (urticaria) and RASH (after four days rashes all over body) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) 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.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-386518 (Patient Link).