chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Ear discomfort, Fatigue, Headache
Clinical narrative: pressure in her ears; fatigue; queasy stomach; bad headache / persistent ongoing dull headaches/ sore head; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (queasy stomach) and HEADACHE (bad headache / persistent ongoing dull headaches/ sore head) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHROID), LEVOTHYROXINE SODIUM (SYNTHROID), RAMIPRIL, SIMVASTATIN, TRAZODONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN [VITAMINS NOS], CALCIUM CITRATE and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (bad headache / persistent ongoing dull headaches/ sore head). On 17-Feb-2021, the patient experienced EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach). At the time of the report, EAR DISCOMFORT (pressure in her ears), FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach) outcome was unknown and HEADACHE (bad headache / persistent ongoing dull headaches/ sore head) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.  Other concomitant medication include Benifiber 2 Tablespoonsful daily.   This case was linked to MOD-2021-336432.; Sender's Comments: This case concerns a 80 year-old, female with no relevant medical history, who experienced the unexpected events of ear discomfort, abdominal discomfort, and expected events of fatigue and headache. The event occurred approximately 4-5  days after the first dose of mRNA-1273 Moderna vaccine. The rechallenge is N/A (the outcome of the events were unknown or not resolved)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Hemiplegia, Multiple sclerosis relapse
Clinical narrative: Multiple sclerosis has been exacerbated; Paralysis in her left side of the body; Weakness in her left side of the body; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (Multiple sclerosis has been exacerbated), HEMIPLEGIA (Paralysis in her left side of the body) and HEMIPARESIS (Weakness in her left side of the body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032821A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MULTIPLE SCLEROSIS (Multiple sclerosis has been exacerbated) (seriousness criterion medically significant), HEMIPLEGIA (Paralysis in her left side of the body) (seriousness criterion medically significant) and HEMIPARESIS (Weakness in her left side of the body) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (Multiple sclerosis has been exacerbated), HEMIPLEGIA (Paralysis in her left side of the body) and HEMIPARESIS (Weakness in her left side of the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.  The second dose was administered via the left arm on 29Sep2021, lot number 006C21A and expiry date: 30Nov2021.  Company comment: This case concerns a 49-year-old, female patient with relevant medical history of Multiple Sclerosis (MS), who experienced the unexpected events of multiple sclerosis, hemiplegia and hemiparesis. The events occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown as no information about the second dose was provided. The medical history of MS, which may cause complications including paralysis and weakness, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-336485 (Patient Link).; Sender's Comments: This case concerns a 49-year-old, female patient with relevant medical history of Multiple Sclerosis (MS), who experienced the unexpected events of multiple sclerosis, hemiplegia and hemiparesis. The events occurred on the same day after administration of the first dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown as no information about the second dose was provided. The medical history of MS, which may cause complications including paralysis and weakness, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose >36 days after; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 032821A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after). On 29-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >36 days after) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-336457 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Reporter, Certified Medical Assistant stated that on  28SEP2021, she was administering the Moderna COVID-19 vaccine to a patient. When she went to get the vial to administer, she noticed that the lot number (Lot #: 017B21A, Expiration date: Unknown) was different than the lot number on the other vials in the same box. She says that they receive the Moderna vaccine vials in boxes, from the state. When she called the health department to talk about this discrepancy, she found out that a few of their vials was taken out and vials of a different lot number were mixed in the box before being sent to them. The vials that had the different lot number had expired at least 2-3 weeks prior. However, by the time she found that out, 8 patients had been administered a dose of the Moderna vaccine from the expired lot on 28SEP2021 and no adverse reactions reported yet.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Was administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-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 first 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Was administered an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment medications reported.   This case was linked to MOD21-148609, MOD21-148614, MOD21-148534, MOD21-148595 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: Sore arm; COVID-19 symptom; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (BUPRENORPHINE/NALOXONE) for an unknown indication.    On 13-Aug-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 PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19 symptom) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Patient has a past medical history of quarantine with COVID-19 symptoms since her boyfriend who was full diagnosed with COVID-19. Patient stated that they both quarantine prior to getting the vaccine. Patient stated that all the symptoms related COVID-19 was cleared up before starting the new job.   This case was linked to MOD-2021-337397 (Patient Link).; Sender's Comments: This case concerns a 32 year-old, female subject,  with a non significant clinical history  who experienced the unexpected events  of PAIN IN EXTREMITY and COVID-19. The events occurred approximately unknown time after the first dose of vaccine.   The rechallenge was unknown The events were considered related to the study drug per the reporter's assessment The benefit-risk relationship of the vaccine is not affected by this report
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients got expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Reporter stated patient has not reported any adverse reactions to the dose so far.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years got a dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years got a dose of the Moderna vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years got a dose of the Moderna vaccine). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years got a dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-336661 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Tachycardia
Clinical narrative: Randomly rapid heart rate for which she hasn't been able to assign a pattern; Constant chest pressure; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure). At the time of the report, TACHYCARDIA (Randomly rapid heart rate for which she hasn't been able to assign a pattern) and CHEST DISCOMFORT (Constant chest pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.  The patient had ECG that came back normal and did not determine a cause.   Cardiac related signs and symptoms: randomly rapid heart rate for which she hasn't been able to assign a pattern and constant chest pressure
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My left injection site arm was sore to the touch.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My left injection site arm was sore to the touch.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (My left injection site arm was sore to the touch.). At the time of the report, VACCINATION SITE PAIN (My left injection site arm was sore to the touch.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-336789 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My left arm injection site was achy and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My left arm injection site was achy and sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced VACCINATION SITE PAIN (My left arm injection site was achy and sore). At the time of the report, VACCINATION SITE PAIN (My left arm injection site was achy and sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.    This case was linked to MOD-2021-336762 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was provided No Treatment information was provided   This case was linked to MOD-2021-336904 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore left injection site arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 031A21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-336832, MOD-2021-336849, MOD-2021-336832 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (first dose) on 28-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (second dose with batch no EN6201) on 19-Feb-2021. Concurrent medical conditions included Down's syndrome.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Pfizer for the 2 dose series but was given a full dose of Moderna as her booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided. Her 2nd dose lot  EN6201 on 19-Feb-2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-337382, MOD-2021-337387 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Worse Migraine episodes; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Worse Migraine episodes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 2029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Migraine (having migraine since the patient was 13 years old). Concomitant products included RIMEGEPANT SULFATE (NURTEC ODT), GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) and IBUPROFEN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Worse Migraine episodes). At the time of the report, MIGRAINE (Worse Migraine episodes) had not resolved.            Treatment information was not provided.  The migraine episodes were more frequent and its worse after the administration of vaccine. Right and left Ora was recorded.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to patient after vaccine expired; vaccine was left out in the fridge post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture) and EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture). On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired). On 22-Aug-2021, PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture) had resolved. On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  The vial did not go through an excursion previously. Only 1 patient was administered the dose. The vial was initially stored in the refrigerator on 22-Aug-2021, 30 days prior to 21-Sep-2021. The vial did not undergo any temperature excursion.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Inappropriate schedule of product administration
Clinical narrative: weak; body pain all over; chills; fever of 37.5 degree Celsius that comes and goes; tired/fatigued; got the 2nd dose about 45 days after the 1st dose; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills), PYREXIA (fever of 37.5 degree Celsius that comes and goes) and FATIGUE (tired/fatigued) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills), PYREXIA (fever of 37.5 degree Celsius that comes and goes), FATIGUE (tired/fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd dose about 45 days after the 1st dose). At the time of the report, ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills) and FATIGUE (tired/fatigued) outcome was unknown, PYREXIA (fever of 37.5 degree Celsius that comes and goes) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd dose about 45 days after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.5 degree celsius (High) fever : 37.5 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-337036.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: weak; body pain all over; chills; fever of 37.5 degree Celsius that comes and goes; tired/fatigued; got the 2nd dose about 45 days after the 1st dose; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills), PYREXIA (fever of 37.5 degree Celsius that comes and goes) and FATIGUE (tired/fatigued) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills), PYREXIA (fever of 37.5 degree Celsius that comes and goes), FATIGUE (tired/fatigued) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd dose about 45 days after the 1st dose). At the time of the report, ASTHENIA (weak), PAIN (body pain all over), CHILLS (chills) and FATIGUE (tired/fatigued) outcome was unknown, PYREXIA (fever of 37.5 degree Celsius that comes and goes) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 2nd dose about 45 days after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 37.5 degree celsius (High) fever : 37.5 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-337036.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A, 031A21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.   This case was linked to MOD-2021-336875, MOD-2021-337387 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.   Vaccine was administered after 24 hours of first puncture  No concomitant medications was reported. Treatment medications was not provided.   This case was linked to MOD-2021-332638 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Feeling abnormal, Gait disturbance, Impaired work ability
Clinical narrative: Walking difficulty; Speech disorder; Impaired work ability; COVID-19; Feeling abnormal; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling abnormal) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 112, 104 patient stated fever of 112, then states Fever of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided. The AEs agent was able to capture are Fever of 112, then states Fever of 104, can't walk, can't talk, can't use the bathroom, sick to her stomach, can't take care of her baby.   Reporter did not allow further contact; Sender's Comments: This case concerns a 23-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected events of gait disturbance, speech disorder, impaired work ability, COVID-19, Feeling abnormal; non-serious expected events of Nausea and Pyrexia. The events occurred on an unknown date after the first dose of Spikevax. The rechallenge was unknown since the Patient experienced AEs after the first dose and at the time of report there is no information about second dose. The events Nausea and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Speech disorder
Clinical narrative: Walking difficulty; Speech disorder; Impaired work ability; COVID-19; Feeling abnormal; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19) and FEELING ABNORMAL (Feeling abnormal) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Walking difficulty), SPEECH DISORDER (Speech disorder), IMPAIRED WORK ABILITY (Impaired work ability), COVID-19 (COVID-19), FEELING ABNORMAL (Feeling abnormal), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 112, 104 patient stated fever of 112, then states Fever of 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information provided. The AEs agent was able to capture are Fever of 112, then states Fever of 104, can't walk, can't talk, can't use the bathroom, sick to her stomach, can't take care of her baby.   Reporter did not allow further contact; Sender's Comments: This case concerns a 23-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected events of gait disturbance, speech disorder, impaired work ability, COVID-19, Feeling abnormal; non-serious expected events of Nausea and Pyrexia. The events occurred on an unknown date after the first dose of Spikevax. The rechallenge was unknown since the Patient experienced AEs after the first dose and at the time of report there is no information about second dose. The events Nausea and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: His wife experienced a slighty sore swollen arm with first vaccine; His wife experienced a slighty sore swollen arm with first vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (His wife experienced a slighty sore swollen arm with first vaccine) and PERIPHERAL SWELLING (His wife experienced a slighty sore swollen arm with first vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Bell's palsy.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (His wife experienced a slighty sore swollen arm with first vaccine) and PERIPHERAL SWELLING (His wife experienced a slighty sore swollen arm with first vaccine). At the time of the report, PAIN IN EXTREMITY (His wife experienced a slighty sore swollen arm with first vaccine) and PERIPHERAL SWELLING (His wife experienced a slighty sore swollen arm with first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-337846 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in right ear; This study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in right ear) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Meniere's disease (duration: 5+ years and status was active.).    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 DEAFNESS UNILATERAL (Hearing loss in right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in right ear) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in right ear) to be possibly related.    Concomitant medications were not provided.   This study includes 18 patients with post-vaccination otologic symptoms.  For this patient, the days to onset of symptoms was between 23 days after each dose.  Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company comment: This case concerns a 73-year-old male subject, with medical history of Meniere's disease, who experienced the unexpected serious event of DEAFNESS UNILATERAL. The event occurred approximately 2 days after the administration of both doses of Moderna COVID-19 Vaccine. The rechallenge was not applicable since no additional dosing will be given. The event was considered related to the vaccine per the reporter's assessment. Patient´s medical history of Meniere's disease, remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 73-year-old male subject, with medical history of Meniere's disease, who experienced the unexpected serious event of DEAFNESS UNILATERAL. The event occurred approximately 2 days after the administration of both doses of Moderna COVID-19 Vaccine. The rechallenge was not applicable since no additional dosing will be given. The event was considered related to the vaccine per the reporter's assessment. Patient´s medical history of Meniere's disease, remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 015M20A and 04L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-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) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Moderna vaccine 044A21A expired on 31 Aug 2021. Vaccine administered to client on 01 Sep 2021 as a third dose.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 36-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-Sep-2021 at 9:56 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient Race is Black
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Swelling face
Clinical narrative: facial swelling; inflammation; This is a spontaneous report received from a contactable consumer. This consumer reported for 16-year-old female patient (reporter's daughter) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in 2021 (at 16-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19 (Dec2020) and Seizures (Dec2020), mast cell syndrome that she has since she was 20-year-old and Mast cell syndrome. The patient's concomitant medications were not reported. On an unknown date in 2021 the patient experienced facial swelling and inflammation. Callers daughters reaction occurred a few hours after the vaccination. The daughters face swelled from her eye down to the mouth area on the left side and the mothers lip blew up. Mother did have her histamine levels checked by her HCP and they were noted to be high. Caller stated that what she was trying to figure out at this time is whether or not she/her daughter should receive the 2nd dose of the vaccine after a reaction from the 1st dose. Mother states that she has received no guidance/direction from her provider or the health department regarding this concern. She states she does not know what to do and states it is our immune system going wonky. Caller understands that an allergic reaction was something that happens fast after the vaccine but questions could it happen later. She stated that she knows the vaccine caused the swelling but only because our systems are over powering themselves. The 16-year-old daughter wants to get her 2nd dose because she is tired of getting quarantined due to close contact. She is tired of having her life uprooted because of it. The patient had not recovered. Reporter's daughter's second vaccination was around 02Sep, she takes birth control because of seizures around ovulation. She ovulated after second vaccine, causing her birth control to not work properly.  The lot number for the vaccine, [Pfizer-BioNTech COVID-19 Vaccine], was not provided and will be requested during follow up.