chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant information received.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  First dose vaccine administered after 1 day from first puncture of vial and second dose administered after 3 days from first puncture of vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains no new information
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used for 2 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days). On 09-Feb-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used for 2 days) had resolved. Not Provided      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 reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: The follow-up information received contain No new information (NNI).
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 8 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Vaccination complication
Clinical narrative: General malaise; Neck is painful to touch; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (General malaise), NECK PAIN (Neck is painful to touch) and FATIGUE (Fatigue) in a 69-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (General malaise), NECK PAIN (Neck is painful to touch) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (General malaise), NECK PAIN (Neck is painful to touch) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Myalgia, Vaccination site warmth
Clinical narrative: warmth at injection site; soreness; very serious fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site), MYALGIA (soreness) and FATIGUE (very serious fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), MYALGIA (soreness) and FATIGUE (very serious fatigue). At the time of the report, VACCINATION SITE WARMTH (warmth at injection site), MYALGIA (soreness) and FATIGUE (very serious fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Heart rate: increased (abnormal) Rapid heart rate for 10 minutes and stopped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has normal BMI.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-333346, MOD-2021-333347 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 2nd dose of Moderna given after expriation of 9/25/201 per medical center.; patient's 2nd had undergone a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Hypertension, LEVOTHYROXINE for Hyperthyroidism.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical  center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per medical  center.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.  2nd dose of Moderna given after expriation of 9/25/201 per medical  center. There is no expiration on the box or vials of the Moderna, vaccine was givn 9/27/21.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Significant follow-up contains patient's Race, dose details, vaccine facility, concomitant medications information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Area is warm to touch; Really swollen, it got to the size of nickle; Pretty good sized bump; Discolored where bump is; It bruised right away; It's feverish on and off/it's feverish on and off; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION SITE BRUISING (It bruised right away), PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea). On 27-Sep-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored where bump is). On an unknown date, the patient experienced VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Sep-2021, PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333519 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area is warm to touch; Really swollen, it got to the size of nickle; Pretty good sized bump; Discolored where bump is; It bruised right away; It's feverish on and off/it's feverish on and off; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced VACCINATION SITE BRUISING (It bruised right away), PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea). On 27-Sep-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored where bump is). On an unknown date, the patient experienced VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 23-Sep-2021, PYREXIA (It's feverish on and off/it's feverish on and off), DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION SITE BRUISING (It bruised right away), VACCINATION SITE MASS (Pretty good sized bump), VACCINATION SITE DISCOLOURATION (Discolored where bump is), VACCINATION SITE WARMTH (Area is warm to touch) and VACCINATION SITE SWELLING (Really swollen, it got to the size of nickle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333519 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered a vial that was punctured more than 12 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-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 29-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago). On 29-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F) 27 and a half hours. Patients received the shot 27 and a half hours after the vial was punctured.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had 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 (had side effects). At the time of the report, VACCINATION COMPLICATION (had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Headache
Clinical narrative: started feeling "the reactions"; nose was inflamed like when you have the flu; lost the sense of smell; lost the sense of taste; headache; fatigue; fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste) and COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever). In September 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), COVID-19 (COVID-19), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     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. Patient received no treatment.; Sender's Comments: This case concerns a 41-year-old, male patient with unknown medical history, who experienced the unexpected non-serious events of vaccination complication, rhinitis, anosmia, ageusia and expected non-serious events of headache, fatigue, pyrexia and covid-19. The events occurred on the 3 days after receiving the first dose of Moderna mRNA-1273 Vaccine. The rechallenge is not applicable as the events reported were only after first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinitis, SARS-CoV-2 test, Vaccination complication
Clinical narrative: started feeling "the reactions"; nose was inflamed like when you have the flu; lost the sense of smell; lost the sense of taste; headache; fatigue; fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste) and COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever). In September 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, VACCINATION COMPLICATION (started feeling "the reactions"), RHINITIS (nose was inflamed like when you have the flu), ANOSMIA (lost the sense of smell), AGEUSIA (lost the sense of taste), COVID-19 (COVID-19), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     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. Patient received no treatment.; Sender's Comments: This case concerns a 41-year-old, male patient with unknown medical history, who experienced the unexpected non-serious events of vaccination complication, rhinitis, anosmia, ageusia and expected non-serious events of headache, fatigue, pyrexia and covid-19. The events occurred on the 3 days after receiving the first dose of Moderna mRNA-1273 Vaccine. The rechallenge is not applicable as the events reported were only after first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleeds in his right nostril; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeds in his right nostril) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (nose bleeds in his right nostril). At the time of the report, EPISTAXIS (nose bleeds in his right nostril) outcome was unknown.            No concomitant medication and treatment information was reported. Reporter stated that the patient experienced nose bleeds in his right nostril since getting the second dose of vaccine, which happened twice in one day but usually the patient experienced a couple of times in a week. Though the reporter also stated that the patient has no history of nose bleed.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccines) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 12L20A and 101M20) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccines). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Sep 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 27, 2021, patient administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion). On Sep 27, 2021, administered expired product (expired 1st dose/receiving a dose from a expired vial) and product storage error (patient's 1st had undergone a temperature excursion) resolved. The reporter did not provide any causality assessments, concomitant product use or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: In follow-up information, patient demographic and event included. On Sep 30, 2021: Non-significant follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A Moderna first dose COVID vaccine was given this morning without realizing before that the expiration was yesterday) 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 information were reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: injection site warmth; I slept longer then normally I do; soreness; Received 3rd dose being not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do), INJECTION SITE PAIN (soreness) and EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 013M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised). On an unknown date, the patient experienced INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do) and INJECTION SITE PAIN (soreness). On 25-Sep-2021, EXTRA DOSE ADMINISTERED (Received 3rd dose being not immunocompromised) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warmth), SLEEP DISORDER (I slept longer then normally I do) and INJECTION SITE PAIN (soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-333240 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Herpes zoster, Ocular hyperaemia, Oral disorder, Swelling face
Clinical narrative: very red swollen lesion inside her mouth; a rash which turned out to be shingles; red swollen eyes; red swollen eyesred swollen eyes; swelling of the right side of her face; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020f21a and 047c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM (CARDIZEM [DILTIAZEM]) and SOTALOL for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that was punctured last evening at 530pm was administered to a patient at 11:15am this morning.) 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 drugs were reported .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Fluid retention, Peripheral swelling, Pruritus
Clinical narrative: Shortness of Breath; Fluid retention; Gradual swelling on legs and thigh; Legs and thighs itching; Legs and thighs peeling; Legs and thighs very red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization) and FLUID RETENTION (Fluid retention) (seriousness criterion hospitalization). In April 2021, the patient experienced PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red). The patient was hospitalized on 30-Mar-2021 due to DYSPNOEA and FLUID RETENTION. At the time of the report, DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) outcome was unknown and PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red) had resolved.            No concomitant medication details were reported. On 29-Mar-2021 patient had a surgery and the day after surgery, had shortness of breath and fluid retention and went to hospital for 2 days for that incident. Two weeks after surgery, patient got gradual swelling on legs and thighs which were itching and peeling and very red. Treatment included antibiotics and after 3 weeks of antibiotics, the swelling, itching and peeling went away.  Company comment: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.; Sender's Comments: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: Shortness of Breath; Fluid retention; Gradual swelling on legs and thigh; Legs and thighs itching; Legs and thighs peeling; Legs and thighs very red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization) and FLUID RETENTION (Fluid retention) (seriousness criterion hospitalization). In April 2021, the patient experienced PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red). The patient was hospitalized on 30-Mar-2021 due to DYSPNOEA and FLUID RETENTION. At the time of the report, DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) outcome was unknown and PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red) had resolved.            No concomitant medication details were reported. On 29-Mar-2021 patient had a surgery and the day after surgery, had shortness of breath and fluid retention and went to hospital for 2 days for that incident. Two weeks after surgery, patient got gradual swelling on legs and thighs which were itching and peeling and very red. Treatment included antibiotics and after 3 weeks of antibiotics, the swelling, itching and peeling went away.  Company comment: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.; Sender's Comments: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On 01-Mar-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was itching.; This morning she had swelling at injection site; She had redness.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching.), VACCINATION SITE SWELLING (This morning she had swelling at injection site) and VACCINATION SITE ERYTHEMA (She had redness.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: This spontaneous reported by a consumer, describes the occurrence of pain in extremity (arm was sore) and feeling hot (arm was sore and hot) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm was sore) and feeling hot (arm was sore and hot). At the time of the report, pain in extremity (arm was sore) and feeling hot (arm was sore and hot) outcome: unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-333395 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Nail infection, Pruritus, Swelling, Vaccination complication
Clinical narrative: COVID toe; Toe swollen and red around nail bed; It had pus; A lot of icky pus; Toe swollen and red around nail bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed). In September 2021, VACCINATION COMPLICATION (COVID toe), SWELLING (Toe swollen and red around nail bed), NAIL INFECTION (It had pus), PRURITUS (A lot of icky pus) and ERYTHEMA (Toe swollen and red around nail bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The pus was absorbed back about in a week and all around the area is healed. No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Vaccination complication
Clinical narrative: COVID fingers; Painful itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (COVID fingers) and PRURITUS (Painful itching) 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 VACCINATION COMPLICATION (COVID fingers) and PRURITUS (Painful itching). In 2021, PRURITUS (Painful itching) had resolved. At the time of the report, VACCINATION COMPLICATION (COVID fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had a reaction to the second dose of the vaccination. The patient experienced painful itching and did go away.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: Hot off and on; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot off and on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 29-Apr-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 FEELING HOT (Hot off and on). At the time of the report, FEELING HOT (Hot off and on) outcome was unknown.            No treatment information was provided.  No relevant concomitant medications were reported.  Patient reported feeling hot off and on afterwards.   This case was linked to MOD-2021-333376 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.; I had mild soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.) and VACCINATION SITE PAIN (I had mild soreness at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had mild soreness at the injection site). On an unknown date, the patient experienced TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.). At the time of the report, TASTE DISORDER (After both doses, I lost my ability to taste seasoned foods, but can taste sweets just fine.) and VACCINATION SITE PAIN (I had mild soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-333473, MOD-2021-333489.