chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Herpes zoster
Clinical narrative: woke up with one eye very swollen shut.A little later on, the other eye was also swollen shut.; The eye doctor said it was shingles of the eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (woke up with one eye very swollen shut.A little later on, the other eye was also swollen shut.) and HERPES ZOSTER (The eye doctor said it was shingles of the eyes) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], MAGNESIUM and FISH OIL for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced EYE SWELLING (woke up with one eye very swollen shut.A little later on, the other eye was also swollen shut.) and HERPES ZOSTER (The eye doctor said it was shingles of the eyes). At the time of the report, EYE SWELLING (woke up with one eye very swollen shut.A little later on, the other eye was also swollen shut.) and HERPES ZOSTER (The eye doctor said it was shingles of the eyes) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       patient took medications for shingles of the eye.   This case was linked to MOD-2021-422302 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injected arm is still swollen after booster shot; swelling wraps around the arm; Injection site itches like crazy; Her arm is still swollen; Very uncomfortable; Injection site redness/there's redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm is still swollen), LIMB DISCOMFORT (Very uncomfortable), VACCINATION SITE ERYTHEMA (Injection site redness/there's redness), VACCINATION SITE SWELLING (Injected arm is still swollen after booster shot; swelling wraps around the arm) and VACCINATION SITE PRURITUS (Injection site itches like crazy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 007C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PERIPHERAL SWELLING (Her arm is still swollen), LIMB DISCOMFORT (Very uncomfortable), VACCINATION SITE ERYTHEMA (Injection site redness/there's redness) and VACCINATION SITE PRURITUS (Injection site itches like crazy). On 19-Dec-2021, the patient experienced VACCINATION SITE SWELLING (Injected arm is still swollen after booster shot; swelling wraps around the arm). At the time of the report, PERIPHERAL SWELLING (Her arm is still swollen), LIMB DISCOMFORT (Very uncomfortable), VACCINATION SITE ERYTHEMA (Injection site redness/there's redness), VACCINATION SITE SWELLING (Injected arm is still swollen after booster shot; swelling wraps around the arm) and VACCINATION SITE PRURITUS (Injection site itches like crazy) had not resolved.            Concomitant products were not provided. Treatment medications were not reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: second shot he had a pretty high fever,he had 106.4F; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (second shot he had a pretty high fever,he had 106.4F) and CHILLS (chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 016M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], MAGNESIUM and FISH OIL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PYREXIA (second shot he had a pretty high fever,he had 106.4F) and CHILLS (chills). At the time of the report, PYREXIA (second shot he had a pretty high fever,he had 106.4F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 106.4f (High) 106.4F.         No treatment information was provided.   This case was linked to MOD-2021-421920 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Influenza like illness, Vertigo
Clinical narrative: Room spinning; Flu like symptoms; Positional dizziness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE in April 2021. Past adverse reactions to the above products included Dizziness with JANSSEN COVID-19 VACCINE.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Room spinning), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS POSTURAL (Positional dizziness) and DIZZINESS (Dizziness) outcome was unknown.            No concomitant medication was provided. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received her flu shot and 2nd dose on the same day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009F21A and 049A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her flu shot and 2nd dose on the same day) had resolved.            Relevant concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-209359 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity
Clinical narrative: No energy; Sore arm; Achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and FATIGUE (Tired) in a 47-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 ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and FATIGUE (Tired). At the time of the report, ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter.  No treatment information provided.  Patient had the symptoms started 24 hours after vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: My arm was sore at the injection site; My arm was red at the injection site; My arm was swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20RT) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.   This case was linked to MOD-2021-422610 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 4th dose received a full dose; 4th dose administered less than 6 months after 3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (4th dose received a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4th dose administered less than 6 months after 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-422792 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna booster vaccine to a patient >12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture). On 22-Dec-2021 at 8:15 AM, EXPIRED PRODUCT ADMINISTERED (Moderna booster vaccine to a patient >12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial opened/punctured on 21-Dec-2021 at 02:00 pm, vial storage at refrigerator, date moved to refrigeration was 10-Dec-2021. The vial did not undergo any previous temperatures excursions. The patient did not experience any symptoms.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: patient is immunocompromised, and received 0.25 mL dose; 1st dose of J&J and 2nd dose Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J & J Vaccine (Received 1st dose.) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with J & J Vaccine.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 27-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna). On 27-Oct-2021, ACCIDENTAL UNDERDOSE (patient is immunocompromised, and received 0.25 mL dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of J&J and 2nd dose Moderna) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine was given as three first doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as three first doses) 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 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as three first doses). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine was given as three first doses) 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Gingival swelling, Injection site swelling, Oropharyngeal discomfort, Swelling
Clinical narrative: "had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"; gum swelling; jaw swelling; "took all of the bumps out of throat that was like scabs on side of tongue"; swelling of neck, gums and injection site; hardness of injection site that "creeps to shoulder to bottom and top of jaw"; swelling at  injection site that "creeps to shoulder to bottom; This spontaneous case was reported by a consumer and describes the occurrence of COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), GINGIVAL SWELLING (gum swelling), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue") and SWELLING (swelling of neck, gums and injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 007B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, HCTZ and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), GINGIVAL SWELLING (gum swelling), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue"), SWELLING (swelling of neck, gums and injection site), VACCINATION SITE INDURATION (hardness of injection site that "creeps to shoulder to bottom and top of jaw") and INJECTION SITE SWELLING (swelling at  injection site that "creeps to shoulder to bottom). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at a dose of every 4-6 hrs. At the time of the report, COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue") and VACCINATION SITE INDURATION (hardness of injection site that "creeps to shoulder to bottom and top of jaw") outcome was unknown and GINGIVAL SWELLING (gum swelling), SWELLING (swelling of neck, gums and injection site) and INJECTION SITE SWELLING (swelling at  injection site that "creeps to shoulder to bottom) had not resolved.            Treatment medications include Magic mouth wash. Patient went to ER around 1-AUG or 2-AUG-2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site induration
Clinical narrative: "had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"; gum swelling; jaw swelling; "took all of the bumps out of throat that was like scabs on side of tongue"; swelling of neck, gums and injection site; hardness of injection site that "creeps to shoulder to bottom and top of jaw"; swelling at  injection site that "creeps to shoulder to bottom; This spontaneous case was reported by a consumer and describes the occurrence of COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), GINGIVAL SWELLING (gum swelling), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue") and SWELLING (swelling of neck, gums and injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 007B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, HCTZ and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), GINGIVAL SWELLING (gum swelling), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue"), SWELLING (swelling of neck, gums and injection site), VACCINATION SITE INDURATION (hardness of injection site that "creeps to shoulder to bottom and top of jaw") and INJECTION SITE SWELLING (swelling at  injection site that "creeps to shoulder to bottom). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at a dose of every 4-6 hrs. At the time of the report, COUGH ("had a bad habit of putting sugar free cough drop candy in mouth at night time to help with nighttime coughing"), SWELLING FACE (jaw swelling), OROPHARYNGEAL DISCOMFORT ("took all of the bumps out of throat that was like scabs on side of tongue") and VACCINATION SITE INDURATION (hardness of injection site that "creeps to shoulder to bottom and top of jaw") outcome was unknown and GINGIVAL SWELLING (gum swelling), SWELLING (swelling of neck, gums and injection site) and INJECTION SITE SWELLING (swelling at  injection site that "creeps to shoulder to bottom) had not resolved.            Treatment medications include Magic mouth wash. Patient went to ER around 1-AUG or 2-AUG-2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster shot to a patient before the 6-month mark; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster shot to a patient before the 6-month mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not sure if she was immunocompromised.  Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: 4 Full doses of the Moderno vaccine; 4 Full doses of the Moderno vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (4 Full doses of the Moderno vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 Full doses of the Moderno vaccine) 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 EXTRA DOSE ADMINISTERED (4 Full doses of the Moderno vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 Full doses of the Moderno vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (4 Full doses of the Moderno vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 Full doses of the Moderno vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: by the middle of the month of May of 2021 his voice began going away & he still does not have it back; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back). At the time of the report, APHONIA (by the middle of the month of May of 2021 his voice began going away & he still does not have it back) had not resolved.            No concomitant medications and no treatment medications were reported. It was reported that patient friend sent him an article about someone else who lost their voice after receiving 2nd dose.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles rash; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (shingles rash) 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. In 2021, the patient experienced HERPES ZOSTER (shingles rash). In 2021, HERPES ZOSTER (shingles rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient took dose 2 on 26-MAR-2021(020B21A) on right arm and booster dose on 17-DEC-2021(032H21A) on left arm. No concomitant and treatment medication was reported.   This case was linked to MOD-2021-423448 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Pain, Pain in extremity
Clinical narrative: does not feel good; sore arm; aches; has no energy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired) in a 5-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired). At the time of the report, MALAISE (does not feel good), PAIN IN EXTREMITY (sore arm), PAIN (aches), ASTHENIA (has no energy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. The patient was treated with antibiotics and steroids.  The patient requested for a phone call to get a response why the patient was experiencing these adverse events and whether the patient should get the second shot or not.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients were all given vaccines past the 30 days expiration mark; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (9 patients were all given vaccines past the 30 days expiration mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  Vial was punctured on 11-Nov-2021 and kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) 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.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The vial was puncture on 11-Nov-2021, dose given and kept in refrigerator after puncture.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient believed she received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048f, 044b21a and 008b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient believed she received an expired vaccine) had resolved.            No treatment drug was reported. No concomitant drug was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non-Significant Follow up received
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) 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.  Reporter stated vial was punctured on 11-Nov-2021 and kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes). At the time of the report, HERPES VIRUS INFECTION (She just got her 2nd dose of Moderna COVID vaccine and she's taking Valtrex/ Caller stated 1/4 of population have Herpes) outcome was unknown.            No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?). On 20-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Moderna boost doses were given today on refrigerator day 31; does Moderna have stability data to support the efficacy of these doses on day 31, or should they be repeated?) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 5 patients who got the Moderna booster after the vial was already punctured 20 times; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939930) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times). On 21-Dec-2021, PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that 25 booster doses were administered intramuscularly in the upper deltoid from 1 vial of Moderna vaccine, which was removed from refrigerator storage at 10am for first puncture and had a last puncture at 4pm.  Administration error was reported to VAERS 752534.  Concomitant medication information was not reported  Treatment information was not reported
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 5 patients who got the Moderna booster after the vial was already punctured 20 times; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939930) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times). On 21-Dec-2021, PRODUCT STORAGE ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP provides identifiers (see attachments) but has no information on concomitant medication for the patients.  No concomitant products were reported.  No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Headache, Nasal congestion
Clinical narrative: backache; congested; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (backache), NASAL CONGESTION (congested) and HEADACHE (headache) 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 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (backache), NASAL CONGESTION (congested) and HEADACHE (headache). At the time of the report, BACK PAIN (backache), NASAL CONGESTION (congested) and HEADACHE (headache) outcome was unknown.            Congested is reported as an event. No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 5 patients who got the Moderna booster after the vial was already punctured 20 times; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939930) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times). On 21-Dec-2021, PRODUCT ADMINISTRATION ERROR (5 patients who got the Moderna booster after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial was removed from the refrigerator storage at 10 am and first puncture then, and the last dose was administered at 4 pm. This administration error has been reported to VAERS already (752547).  No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-423214, MOD-2021-423227, MOD-2021-423242, MOD-2021-423248 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: my 2 daughters were injected were all poorly by the end of the day; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) 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 19-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day). At the time of the report, VACCINATION COMPLICATION (my 2 daughters were injected were all poorly by the end of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-423278 (Patient Link).