chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sick feeling; sore back; Achy; Fatigue; Nausea; I had fever and fatigue for the first two doses, a sick feeling; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.    On 10-Feb-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 ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ILLNESS (sick feeling), BACK PAIN (sore back), PAIN (Achy), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (I had fever and fatigue for the first two doses, a sick feeling) outcome was unknown.            Concomitant medications include Carbamazepine XR 100mg. Treatment medications include Aspirin   This case was linked to MOD-2021-345452, MOD-2021-345470 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Feeling abnormal
Clinical narrative: little brain foggy (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (little brain foggy (1st dose)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Kidney transplant. Concurrent medical conditions included Immunocompromised. Concomitant products included Prednisone 5 mg, BELATACEPT and MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Kidney transplant.    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 FEELING ABNORMAL (little brain foggy (1st dose)). At the time of the report, FEELING ABNORMAL (little brain foggy (1st dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is immunocompromised, because she had a kidney transplant and is taking immunosuppressive medications.  Treatment Tylenol after third dose   This case was linked to MOD-2021-345487 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeding disorder, Headache, Insomnia, Nausea
Clinical narrative: slept on and off; neck pain; I couldn't eat; sore arm; Fever; Headache; Nausea; hip pain/right hip hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.   On 12-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 27-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 INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt) had resolved.            This case was linked to MOD-2021-345452, MOD-2021-345463, MOD-2021-345452 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: slept on and off; neck pain; I couldn't eat; sore arm; Fever; Headache; Nausea; hip pain/right hip hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.   On 12-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 27-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 INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt) had resolved.            This case was linked to MOD-2021-345452, MOD-2021-345463, MOD-2021-345452 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported  that date the vial was initially stored in the refrigerator: 02-Sep-2021.  Number of doses/vials 10-dose vial  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-345460, MOD-2021-345910, MOD-2021-345833, MOD-2021-345457, MOD-2021-345456, MOD-2021-345931, MOD-2021-345620, MOD-2021-345565, MOD-2021-345619, MOD-2021-345642, MOD-2021-345666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant follow-up appended _ Reported added & Batch No. updated
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered from a vial punctured for more than 12 hours; patient was administered yesterday (6Oct2021) a dose of the Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna). On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered yesterday (6Oct2021) a dose of the Moderna) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications include blood pressure, cholesterol, anticoagulant and an inhaler.  No treatment medications were provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Erythema, SARS-CoV-2 test
Clinical narrative: Left arm was red with a circle; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm was red with a circle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (left arm was red with a circle). At the time of the report, ERYTHEMA (left arm was red with a circle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Antibody test: positive (Positive) Positive. In January 2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  About a month ago, the patient felt weird where the patient did a home test and result came back positive. The patient queried how the vaccine works and how can it make antibodies.   This case was linked to MOD-2021-345547 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: had Moderna for 1st and 2nd doses; given Pfizer as booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose). On 07-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (had Moderna for 1st and 2nd doses; given Pfizer as booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had third dose on 7-OCT-2021 with lot number FF8839, expiration date was 01-FEB-2022 at 0.3 ml intramuscularly.   No concomitant medication was reported. No treatment drug details was reported.   This case was linked to MOD-2021-345540 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
Clinical narrative: congested; she felt weird; Felt a little fatigued the next day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she felt weird), NASAL CONGESTION (congested) and FATIGUE (Felt a little fatigued the next day) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FATIGUE (Felt a little fatigued the next day). In September 2021, the patient experienced FEELING ABNORMAL (she felt weird). On an unknown date, the patient experienced NASAL CONGESTION (congested). At the time of the report, FEELING ABNORMAL (she felt weird), NASAL CONGESTION (congested) and FATIGUE (Felt a little fatigued the next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, negative (Negative) Negative and negative (Negative) Negative.         No concomitant drug details were reported. No treatment details were reported.  She did a home test and it came back positive, did additional tests and a pcr test that came back negative, did another pcr test and it came back negative, conducted an antibody test where it came back positive.   This case was linked to MOD-2021-345514 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        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-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received includes: Updated batch number, expiration date and added new reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  On 06 Oct 2021 vaccine was moved from freezer to refrigerator.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for Covid) in a 45-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient got the 1st dose of the Moderna COVID-19 Vaccine and tested positive for COVID 3 days later. The patient was exposed to COVID at work & also had family members who tested positive around that time. The patient received monoclonal antibodies as treatment for COVID.; Sender's Comments: This case concerns a 45-year-old, female patient, with no disclosed medical history but with exposure to Covid at work and with family member, who experienced the non-serious, unexpected, AESI  event of Covid-19. The event occurred 3 days after first Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The patient's exposure to Covid-19 and only one dose of vaccine received remain as confounders to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot
Clinical narrative: She's been feeling kind of funny, like hot and burning.; She's been feeling kind of funny, like hot and burning/She states her body is burning; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT and BURNING SENSATION in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced FEELING HOT and BURNING SENSATION. The patient was treated with TYLENOL for Adverse event, at a dose of 500 mg. At the time of the report, FEELING HOT and BURNING SENSATION had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The patient reported that she has been taking the red, blue, and white Tylenol 500 mg. She stated that she does not have a temperature.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching in her joints), MYALGIA (General aching all over) and FATIGUE (Feeling tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Aching in her joints), MYALGIA (General aching all over) and FATIGUE (Feeling tired). At the time of the report, ARTHRALGIA (Aching in her joints), MYALGIA (General aching all over) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-345651 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Night sweats
Clinical narrative: Hot Flashes; Night Sweats; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats). At the time of the report, HOT FLUSH (Hot Flashes) and NIGHT SWEATS (Night Sweats) had not resolved.      No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke after receiving vaccine/multiple strokes after receiving; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke after receiving vaccine/multiple strokes after receiving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.  Company comment: This case concerns a female patient of an unknown age no reported medical history, who experienced the unexpected events of multiple strokes after receiving the vaccine. The events occurred following an unspecified duration after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details about dosing and scheduled was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Stroke is an adverse event of special interest.   This case was linked to MOD-2021-345450 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age no reported medical history, who experienced the unexpected events of multiple strokes after receiving the vaccine. The events occurred following an unspecified duration after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details about dosing and scheduled was not disclosed. Causality for the reported events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Stroke is an adverse event of special interest.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345445, MOD-2021-345460, MOD-2021-345565, MOD-2021-345620, MOD-2021-345666, MOD-2021-345833, MOD-2021-345910, MOD-2021-345931 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 08-Oct-2021, Follow-up received on 08-oct-2021 updated batch number.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Number of doses/vials 10-dose vial. Date the vial was initially stored in the refrigerator: 02-Sep-2021.  Number of doses/vials: 14 doses, which were administered  Date the vial was initially stored in the refrigerator: 30-Sep-2021.  No concomitant medication information were provided. No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up information received on 08-Oct-2021: Significant follow-up appended, Reported added and Batch No. updated.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Each injection increased her ability to function, increased heart rate variability, some of the effect wore off to some degree between vaccines, her overall condition has improved after vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Each injection increased her ability to function, increased heart rate variability, some of the effect wore off to some degree between vaccines, her overall condition has improved after vaccination.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 050E21A) for COVID-19 vaccination.     Concurrent medical conditions included Disability (Chronic illness with long term disability.) and Illness (Chronic illness). Concomitant products included PREDNISONE and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-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 THERAPEUTIC RESPONSE UNEXPECTED (Each injection increased her ability to function, increased heart rate variability, some of the effect wore off to some degree between vaccines, her overall condition has improved after vaccination.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Each injection increased her ability to function, increased heart rate variability, some of the effect wore off to some degree between vaccines, her overall condition has improved after vaccination.) outcome was unknown.            Other concomitant product use included medications for pain as needed.  Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter states that the date vial was initially stored in the refrigerator was on  02-Sep-2021 and the number of doses/vials was 10 dose vial. It was reported that original expiration was on 02-Mar-2021 and states the expiration was changed to 02-Oct-2021.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345460, MOD-2021-345565, MOD-2021-345910, MOD-2021-345833, MOD-2021-345457, MOD-2021-345456, MOD-2021-345931, MOD-2021-345620, MOD-2021-345619, MOD-2021-345666 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Significant follow-up appended which included reporter information and batch number was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: general achiness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (general achiness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MYALGIA (general achiness). At the time of the report, MYALGIA (general achiness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided   This case was linked to MOD-2021-345609 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: received dose from expired vial; second Moderna dose administered greater than 35 days from first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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. On 07-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna dose administered greater than 35 days from first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided. Vial opened on 30-09-2021.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received included patient characteristics, batch/lot number, anatomical location of vaccine and new event were added.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. original expiration was 2Mar2021 states the expiration was changed to 2Oct2021. Nurse states she wrote expired on the box but the doses were accidentally administered .   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: significant follow up appended : Reporter / Lot no / Expiration Date Updated .
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke after receiving 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke after receiving vaccine) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO Concomitant medication was reported NO treatment medication was reported  Company comment: This case concerns a subject of unknown age and gender, with no reported medical history, who experienced the unexpected event of CEREBROVASCULAR ACCIDENT. The event occurred on an unknown moment after the dose of Spikevax. . The rechallenge was not applicable, as there is no information that states vaccination dose number or any information about the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-345616, MOD-2021-345450, MOD-2021-345677 (Patient Link).; Sender's Comments: This case concerns a subject of unknown age and gender, with no reported medical history, who experienced the unexpected event of CEREBROVASCULAR ACCIDENT. The event occurred on an unknown moment after the dose of Spikevax. . The rechallenge was not applicable, as there is no information that states vaccination dose number or any information about the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: mild rash; This spontaneous case was reported by a nurse and describes the occurrence of RASH (mild rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH (mild rash). At the time of the report, RASH (mild rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-345655 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: people who are getting a 3rd Moderna shot who are not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (people who are getting a 3rd Moderna shot who are not immunocompromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (people who are getting a 3rd Moderna shot who are not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (people who are getting a 3rd Moderna shot who are not immunocompromised) had resolved.            No concomitant medications were not reported. No treatment medications were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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. In 2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102 (High) 102 degree Body temperature.         Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Fatigue was the major issue since receiving the vaccine.   This case was linked to MOD-2021-345455 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: unspecified side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (unspecified side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 (unspecified side effects). At the time of the report, VACCINATION COMPLICATION (unspecified side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site mass
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (left a little bump that's still there) and COVID-19 (after vaccination) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. September 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. In September 2021, patient experienced vaccination site mass (left a little bump that's still there). On Oct 6, 2021, patient experienced COVID-19 (after vaccination). At the time of the report, vaccination site mass (left a little bump that's still there): not resolved and COVID-19 (after vaccination) outcome: unknown. No concomitant medications or treatment medications reported. Patient doesn't know when he will get the second dose. Patient found out that he had COVID-19. It is possible he was  infected before the shot, but he doesn't know. Most recent follow-up information incorporated: On Oct 7, 2021: Follow-up information contained no new information. Sender's comments: This case concerns a 63-year-old male patient with no particular medical history, who experienced an unexpected event of special interest COVID-19 and unexpected vaccination site mass. The events occurred after the first dose of Moderna COVID-19 vaccine; however, the exact time to onset unknown since vaccination date not provided. Re-challenge unknown since there is no information regarding the second dose and occurrence of the event. The benefit-risk relationship of drug not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurst/it's getting a little bit worse by the hour; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurst/it's getting a little bit worse by the hour) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), GABAPENTIN, METHOCARBAMOL, CYCLOBENZAPRINE and ARIPIPRAZOLE for an unknown indication.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm hurst/it's getting a little bit worse by the hour). At the time of the report, PAIN IN EXTREMITY (Arm hurst/it's getting a little bit worse by the hour) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with a mild case of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with a mild case of COVID-19) 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 22-Sep-2021, the patient experienced COVID-19 (Diagnosed with a mild case of COVID-19). At the time of the report, COVID-19 (Diagnosed with a mild case of COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient wished to know when he would be eligible to receive the Flu vaccine.; Sender's Comments: This case concerns a male patient  of an unknown age with no relevant medical history who experienced non-serious unexpected event of COVID-19. Temporal relationship is unknown since date of vaccination was not provided per SD. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. Based on biological implausibility, causal relationship between the reported event COVID-19 is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: This report concerns a male patient of unknown age who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The report states that the patient was vaccinated with 2 doses of mRNA-1273. Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273  is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Vaccination complication
Clinical narrative: Headache; General fatigue; I was sick for a day or two; Vaccination related malaise; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, VACCINATION COMPLICATION, HEADACHE, and FATIGUE in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACYCLOVIR, BABY ASPIRIN, and HYDRALAZINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ILLNESS and VACCINATION COMPLICATION. On an unknown date, the patient experienced HEADACHE and FATIGUE. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and TYLENOL for Adverse event, at an unspecified dose and frequency. In January 2021, VACCINATION COMPLICATION had resolved. At the time of the report, ILLNESS had resolved, HEADACHE, and FATIGUE outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-345824 (Patient Link).