chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Illness, Myalgia
Clinical narrative: sick for 3 days; weakness; low grade fever; chills but not that bad; terrible muscle pain during the night; he next day felt better and by the third day felt tired but was able to do her activities; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (seasonal allergies), Drug allergy (Phenergan) and Drug allergy (Sulfa drug). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and ALPRAZOLAM (XANAX) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad), MYALGIA (terrible muscle pain during the night) and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg four times per day. At the time of the report, ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) had resolved and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications was reported as Metoprolol extender release 25mg daily, Lamictol 12.5mg/day. Treatment medications reported by reporter are Zinc 1 tab for the first two days Amoxicillin 875mg twice a day started yesterday (10Sept)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: sick for 3 days; weakness; low grade fever; chills but not that bad; terrible muscle pain during the night; he next day felt better and by the third day felt tired but was able to do her activities; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy (seasonal allergies), Drug allergy (Phenergan) and Drug allergy (Sulfa drug). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and ALPRAZOLAM (XANAX) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad), MYALGIA (terrible muscle pain during the night) and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg four times per day. At the time of the report, ILLNESS (sick for 3 days), ASTHENIA (weakness), PYREXIA (low grade fever), CHILLS (chills but not that bad) and MYALGIA (terrible muscle pain during the night) had resolved and FATIGUE (he next day felt better and by the third day felt tired but was able to do her activities) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications was reported as Metoprolol extender release 25mg daily, Lamictol 12.5mg/day. Treatment medications reported by reporter are Zinc 1 tab for the first two days Amoxicillin 875mg twice a day started yesterday (10Sept)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered past the 30 day refrigeration time; Improper storage of unused product; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Improper storage of unused product) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.  Third shot info of patient includes  Date administered: 18AUG2021, Lot number: 008C21A , Expiration date: 31OCT2021 , Date refrigerated: 20APR2021, Temperature changes (in F): 41
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site.) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21O, #013L20A and #021M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (soreness in the injection site.). At the time of the report, VACCINATION SITE PAIN (soreness in the injection site.) outcome was unknown.            No Concomitant use were reported.  No Treatment were reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Non-Significant F/U Case.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Fatigue, Vaccination site pain
Clinical narrative: pain in the arm on all doses; feeling tired on 1st 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses). At the time of the report, VACCINATION SITE PAIN (pain in the arm on all doses) and FATIGUE (feeling tired on 1st 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal.         Concomitant products also included  Steroids.  No treatment medication provided. RT-PCR test which came back negative.   This case was linked to MOD-2021-316580, MOD-2021-316515 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Product preparation error
Clinical narrative: Patient is currently pregnant with an unknown due date; Mixed Moderna + Pfizer vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date) and PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 for COVID-19 vaccination.    No Medical History information was reported.   On 20-Aug-2021, the patient started BNT162B2 (unknown route) 1 dosage form. On 10-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, BNT162B2 (unknown route) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 10-Sep-2021, the patient experienced PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date). On 10-Sep-2021, PRODUCT PREPARATION ERROR (Mixed Moderna + Pfizer vaccine) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is currently pregnant with an unknown due date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.  The pharmacist reported that the patient is currently pregnant with an unknown due date, possibly in November 2021.  This case concerns a 25 year old pregnant female, who experienced Maternal exposure during pregnancy and Product Preparation error on the day of receiving vaccine. The rechallenge is not applicable since this is the firt time patient received Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 25 year old pregnant female, who experienced Maternal exposure during pregnancy and Product Preparation error on the day of receiving vaccine. The rechallenge is not applicable since this is the firt time patient received Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19 on September 7th; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Overweight and Smoker (former smoker). Concurrent medical conditions included Hypertension.   On 06-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) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved and DRUG INEFFECTIVE (Tested positive for COVID-19 on September 7th) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.; Sender's Comments: This case concerns a 55-year-old female patient, former smoker, overweight and hypertensive, who experienced the unexpected event of COVID-19, vaccination failure was considered as an additional event. The event occurred approximately 4 months after the second dose of Spikevax. The event was considered related to the product per the reporter's assessment. The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Kidney infection, Pyrexia
Clinical narrative: kidneys' and sick; my side starting hurting; and hard to breathe; fever; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (kidneys' and sick) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-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 KIDNEY INFECTION (kidneys' and sick) (seriousness criterion medically significant), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever). At the time of the report, KIDNEY INFECTION (kidneys' and sick), DISCOMFORT (my side starting hurting), DYSPNOEA (and hard to breathe) and PYREXIA (fever) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up appended as live follow up included events added; Sender's Comments: This case concerns a 62-year-old male subject who experienced the serious event of kidney infection, and non-serious events of discomfort, dyspnoea, and pyrexia. The events occurred after the administration of the second dose of Spikevax (event onset from last dose not reported). The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 003C21A and 014C21A) for COVID-19 immunization. Concurrent medical conditions included prediabetes since Jan 28, 2021. Concomitant products included Zyrtec (cetirizine hydrochloride) for allergy. On Aug 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 9, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 12, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA). On Sep 10, 2021, product administered to patient of inappropriate age (13-year-old girl given Moderna vaccine not approved by the FDA) resolved. The reporter did not provide any causality assessments or treatment information. This case linked to MOD-2021-284575 (patient link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: felt really bad; nauseated; fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No medical History was reported.  Concomitant products included MELOXICAM, VERAPAMIL, TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) and PRAVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101 (High) Fever of 101 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had no known allergy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received significant information - Events Outcome updated.
Age: 79.0
Sex: F
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 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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) (Unknown) was unknown.       No concomitant medication is provided by reporter. No treatment information is provided by reporter. Patient medical history include some medical training and a pre -existing medical condition.  This case was linked to MOD-2021-316913 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        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.  Date refrigerated: 20 Apr 2021  Temperature changes (in F): 42
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) to be not applicable.    No Concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: felt a slight heavy feeling in that arm.; After the first dose he experienced a slight pain in his left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm). On 14-Mar-2021, VACCINATION SITE DISCOMFORT (felt a slight heavy feeling in that arm.) and VACCINATION SITE PAIN (After the first dose he experienced a slight pain in his left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Antibiotics  Treatment information included Windmill exercises   This case was linked to MOD-2021-315705 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Long QT syndrome
Clinical narrative: Long QT syndrome; This spontaneous case was reported by a consumer and describes the occurrence of LONG QT SYNDROME (Long QT syndrome) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LONG QT SYNDROME (Long QT syndrome). At the time of the report, LONG QT SYNDROME (Long QT syndrome) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment drug information provided. No concomitant drug information provided.  Company comment- This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.; Sender's Comments: This case concerns an unknown age male subject with unknown relevant medical history, who experienced the unexpected event of LONG QT SYNDROME. The event occurred on an unknown date and there are no vaccination dates available. The rechallenge was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Despite the event Long QT syndrome being automatically upgraded to serious as per IME list it was manually overridden according to provided narrative and medical judgement. Additional query was sent to obtain missing information and clarify details regarding this event.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got firm sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got firm sickness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Wasp sting on 21-Aug-2021 and Sickness (stung by a wasp then week after that the wasp site also got firm sickness.).    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 ILLNESS (got firm sickness). At the time of the report, ILLNESS (got firm sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant medications and treatment information's ware not provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: tiredness; headaches; having a lot of fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness). On 08-Sep-2021, PYREXIA (having a lot of fever), HEADACHE (headaches) and FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling hot, Peripheral swelling
Clinical narrative: Arm has swollen up as big as a softball/swell up; Extremely hot; Big bruise; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-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 PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise). At the time of the report, PERIPHERAL SWELLING (Arm has swollen up as big as a softball/swell up), FEELING HOT (Extremely hot) and CONTUSION (Big bruise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Invalid doses administered; 400 doses were refrigerated beyond 30 days and administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) 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) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered). On 19-May-2021, EXPIRED PRODUCT ADMINISTERED (Invalid doses administered) and PRODUCT STORAGE ERROR (400 doses were refrigerated beyond 30 days and administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Number of doses/vials 1230 doses administered but approximately 400 doses were refrigerated beyond 30 days and administered. Date the vial was initially stored in the refrigerator 13Apr2021 and administrated between 19May2021 and through June and July 2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; I got the vaccine last Thursday but it's still swollen, red, and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) 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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting). At the time of the report, VACCINATION SITE SWELLING (I got the vaccine last Thursday but it's still swollen, red, and hurting), VACCINATION SITE ERYTHEMA (I got the vaccine last Thursday but it's still swollen, red, and hurting) and VACCINATION SITE PAIN (I got the vaccine last Thursday but it's still swollen, red, and hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Headache, Pyrexia, Vomiting
Clinical narrative: Now have a slight headache; High fever; Vomitting; Joint pain; So bad I could not walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (So bad I could not walk), HEADACHE (Now have a slight headache), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 GAIT INABILITY (So bad I could not walk), HEADACHE (Now have a slight headache), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain). At the time of the report, GAIT INABILITY (So bad I could not walk), PYREXIA (High fever), VOMITING (Vomitting) and ARTHRALGIA (Joint pain) had resolved and HEADACHE (Now have a slight headache) outcome was unknown.            Patient reported the events after receiving the second dose of Moderna vaccine the side effects were intense.  No concomitant medication details was provided. No treatment medication details was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported Vaccine was administered on 09Sep2021 patient's second dose. HCP said patient was not experiencing any symptoms, patient left fine with no issues.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non sig fup: We have already completed a VAERS report for this incident. The temporary number is 640223.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-317635, MOD-2021-317617 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe fatigue). At the time of the report, FATIGUE (Severe fatigue) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: something bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (something bad) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (something bad). At the time of the report, FEELING ABNORMAL (something bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had vaccine January and February, tested positive for covid; Diagnosed positive covid-19 yesterday; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive covid-19 yesterday) and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced COVID-19 (Diagnosed positive covid-19 yesterday). On an unknown date, the patient experienced DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid). At the time of the report, COVID-19 (Diagnosed positive covid-19 yesterday) outcome was unknown and DRUG INEFFECTIVE (had vaccine January and February, tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Cough, Speech disorder
Clinical narrative: Loss of smell; Cough; Difficult to talk; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) 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.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk). At the time of the report, ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) outcome was unknown.            Doctor stated that the these symptoms recur every month.  Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Illness, SARS-CoV-2 test
Clinical narrative: so sick now; developed a thrush inf; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) 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 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf). At the time of the report, ILLNESS (so sick now) and CANDIDA INFECTION (developed a thrush inf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-317625 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: week of feeling sick; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) 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. In September 2021, the patient experienced MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, MALAISE (week of feeling sick), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Musculoskeletal chest pain
Clinical narrative: chest pain; Chest tenderness; feeling of fluttering In Chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) 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 CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest). At the time of the report, CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: with no energy; was just tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was just tired) and ASTHENIA (with no energy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A; and 071A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Depression.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (was just tired) and ASTHENIA (with no energy). At the time of the report, FATIGUE (was just tired) and ASTHENIA (with no energy) outcome was unknown.            Concomitant medications included unspecified antidepressant and blood pressure medication.  No treatment information was reported.   This case was linked to MOD-2021-047855 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.