chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Heat in my chest; Achiness in my chest; Pain in my arm; Achiness; Little bit of a fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever). At the time of the report, CHEST DISCOMFORT (Heat in my chest), CHEST PAIN (Achiness in my chest), PAIN IN EXTREMITY (Pain in my arm), MYALGIA (Achiness) and PYREXIA (Little bit of a fever) 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 product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-405046, MOD-2021-405481 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Pain, Pain in extremity
Clinical narrative: Felt heat in chest; Felt achiness in chest; Pain in arm; Achiness; chills; Little bit of a fever; This spontaneous case was reported by another health care professional and describes the occurrence of CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever). At the time of the report, CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-405046, MOD-2021-405428 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt heat in chest; Felt achiness in chest; Pain in arm; Achiness; chills; Little bit of a fever; This spontaneous case was reported by another health care professional and describes the occurrence of CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever). At the time of the report, CHEST DISCOMFORT (Felt heat in chest), CHEST PAIN (Felt achiness in chest), PAIN IN EXTREMITY (Pain in arm), PAIN (Achiness), CHILLS (chills) and PYREXIA (Little bit of a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-405046, MOD-2021-405428 (Patient Link).
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: The pain is now down a little bit further in his back.; Neck pain which has continued up to today and is worsening; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck pain which has continued up to today and is worsening) and BACK PAIN (The pain is now down a little bit further in his back.) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 025J20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Neck pain which has continued up to today and is worsening). On 06-Dec-2021, the patient experienced BACK PAIN (The pain is now down a little bit further in his back.). The patient was treated with IBUPROFEN at a dose of 1 UNK and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain which has continued up to today and is worsening) and BACK PAIN (The pain is now down a little bit further in his back.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter.  Patient had minimal relief after taking ibuprofen and tylenol for the pain but has not helped significantly.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021 at 11:24 AM, the patient received third 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021 at 11:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 04-Nov-2021 at 11:24 AM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-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.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Nov-2021 at 12:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. 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 11-Nov-2021 at 12:57 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 11-Nov-2021 at 12:57 PM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided          Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose) in a 41-year-old male patient 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) .25 milliliter. On 06-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose). On 06-Dec-2021, ACCIDENTAL UNDERDOSE (Received half dose booster instead of first full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. It was reported that patient has not received the primary series. Pharmacist was trying to get him to come in to administer the other 0.25 ml to make up a 0.5 ml first dose on the same day. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: they had an allergic reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERSENSITIVITY (they had an allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (they had an allergic reaction). At the time of the report, HYPERSENSITIVITY (they had an allergic reaction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 53.0
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 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021 at 11:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 11:55 AM, 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.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 107 patients received the expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:38 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021 at 9:38 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine). On 19-Aug-2021 at 9:38 AM, EXPIRED PRODUCT ADMINISTERED (107 patients received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inadvertently given the second dose at day 11; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inadvertently given the second dose at day 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. The patient received first dose of Moderna vaccine and then inadvertently given the second dose at day 11 so he did not had the 28 days window.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Myalgia
Clinical narrative: strong body aches after booster; chills after booster; headache after booster; vomiting; nausea; fever 99.7°F; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MYALGIA (strong body aches after booster), CHILLS (chills after booster), PYREXIA (fever 99.7°F) and HEADACHE (headache after booster) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 026B21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MALAISE (not feeling well), PYREXIA (fever 99.7°F) and NAUSEA (nausea). On 06-Dec-2021, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced MYALGIA (strong body aches after booster), CHILLS (chills after booster) and HEADACHE (headache after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 04-Dec-2021, MALAISE (not feeling well) had resolved. On 05-Dec-2021, NAUSEA (nausea) had resolved. At the time of the report, MYALGIA (strong body aches after booster), CHILLS (chills after booster), PYREXIA (fever 99.7°F), HEADACHE (headache after booster) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Body temperature: 99.7 (High) 99.7°F.         No concomitant medications were reported.  On Dec-2021 patient experienced strong body aches, chills and headache.   This case was linked to MOD-2021-405666, MOD-2021-405674 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: strong body aches after booster; chills after booster; headache after booster; vomiting; nausea; fever 99.7°F; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), MYALGIA (strong body aches after booster), CHILLS (chills after booster), PYREXIA (fever 99.7°F) and HEADACHE (headache after booster) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 026B21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MALAISE (not feeling well), PYREXIA (fever 99.7°F) and NAUSEA (nausea). On 06-Dec-2021, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced MYALGIA (strong body aches after booster), CHILLS (chills after booster) and HEADACHE (headache after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 04-Dec-2021, MALAISE (not feeling well) had resolved. On 05-Dec-2021, NAUSEA (nausea) had resolved. At the time of the report, MYALGIA (strong body aches after booster), CHILLS (chills after booster), PYREXIA (fever 99.7°F), HEADACHE (headache after booster) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Body temperature: 99.7 (High) 99.7°F.         No concomitant medications were reported.  On Dec-2021 patient experienced strong body aches, chills and headache.   This case was linked to MOD-2021-405666, MOD-2021-405674 (Patient Link).
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 107 patients who were administered with the vaccine past the published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. No concomitant medications were reported.   This case was linked to MOD-2021-405476 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Eye irritation, Eye pruritus, Hypersensitivity, Lacrimation increased
Clinical narrative: my eyes are watering; severe allergic reaction; eye issue started on the corner of the left eye/spread to both eyes; itching eyes/itchiness; irritation eyes / irritation of my eyes; inflammation/inflammation around the eyes; This spontaneous case was reported by a non-health professional and describes the occurrence of OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes) and EYE INFLAMMATION (inflammation/inflammation around the eyes). On an unknown date, the patient experienced LACRIMATION INCREASED (my eyes are watering) and HYPERSENSITIVITY (severe allergic reaction). The patient was treated with FLUOROMETHOLONE (ophthalmic) for Eye inflammation and Itching eyes, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) had not resolved and HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.            Patient reported that eye issue was a mild problem but now it is an acute problem. He is waiting to get the topical steroid ointment. Patient booster shot is schedule for the 15-DEC-2021. No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: my eyes are watering; severe allergic reaction; eye issue started on the corner of the left eye/spread to both eyes; itching eyes/itchiness; irritation eyes / irritation of my eyes; inflammation/inflammation around the eyes; This spontaneous case was reported by a non-health professional and describes the occurrence of OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes) and EYE INFLAMMATION (inflammation/inflammation around the eyes). On an unknown date, the patient experienced LACRIMATION INCREASED (my eyes are watering) and HYPERSENSITIVITY (severe allergic reaction). The patient was treated with FLUOROMETHOLONE (ophthalmic) for Eye inflammation and Itching eyes, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (eye issue started on the corner of the left eye/spread to both eyes), EYE PRURITUS (itching eyes/itchiness), EYE IRRITATION (irritation eyes / irritation of my eyes), EYE INFLAMMATION (inflammation/inflammation around the eyes) and LACRIMATION INCREASED (my eyes are watering) had not resolved and HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.            Patient reported that eye issue was a mild problem but now it is an acute problem. He is waiting to get the topical steroid ointment. Patient booster shot is schedule for the 15-DEC-2021. No relevant concomitant medications were reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021 at 9:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021 at 9:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). On 19-Aug-2021 at 9:35 AM, 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 medication was reported by reporter. No treatment medication was reported by reporter.  Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: feeling very achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling very achy) and FATIGUE (tired) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 MYALGIA (feeling very achy) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (feeling very achy) and FATIGUE (tired) outcome was unknown.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2021-405640, MOD-2021-405674 (Patient Link).
Age: 57.0
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 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:48 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021 at 11:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 11:48 AM, 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 provided. No treatment medications were provided.  Vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received the expired vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021 at 11:36 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. 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 18-Nov-2021 at 11:36 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.). On 18-Nov-2021 at 11:36 AM, EXPIRED PRODUCT ADMINISTERED (patient received the expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that upon delivery of each vaccine order (021B21A- feb-2021  and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received contains patient demographics.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021 at 11:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021 at 11:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 18-Nov-2021 at 11:35 AM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that upon delivery of each vaccine order (021B21A- feb-2021  and 021B21A- MAR-2021. the vaccines were placed into the freezer the same day they were delivered. The vial from the freezer was removed and was put it in the refrigerator the day before it was used. Thus, vaccines were not in the fridge for more than a day unless patients did not appear for their vaccine.  No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2021: Follow-up received on 06-DEC-2021 included suspect product and patient demographics details.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: body ache; sore left injection site arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever). At the time of the report, PAIN (body ache), VACCINATION SITE PAIN (sore left injection site arm) and PYREXIA (fever) outcome was unknown.        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.   This case was linked to MOD-2021-404697, MOD-2021-404586 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Patient ended in the hospital whit blood clots in both of her lungs; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood (Patient had a blood clot 16 yeas ago after a 40hs flight.). Concurrent medical conditions included Allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with HEPARIN for Adverse event, at a dose of 1 dosage form and APIXABAN (ELIQUIS) for Adverse event, at a dose of 1 dosage form. At the time of the report, PULMONARY THROMBOSIS (Patient ended in the hospital whit blood clots in both of her lungs) had not resolved.            Patient was prescribed many blood thinners at the hospital. It was reported that patient was taking an unspecified allergy pill and some herbal medications. Patient has profuse spouts of coffin. Company comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected event of lung thrombosis, which required hospitalization. The events occurred approximately two weeks after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The medical history of prior blood clots remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: New serious event (thrombosis)added, seriousness criteria upgraded, patient demographics, vaccination date, batch/lot number, treatment, concomitant medication added, narrative updated; Sender's Comments: Company comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected event of lung thrombosis, which required hospitalization. The events occurred approximately two weeks after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. The medical history of prior blood clots remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Jul2021 10:45 (Lot number: EW0196) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes type II" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: no. Concomitant medication(s) included: LOSARTAN; JANUMET. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Jul2021 22:00, outcome "not recovered", described as "upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area."; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 28Jul2021 22:00, outcome "not recovered" and all described as "Severe, upper left arm pain at injection site & under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area."; PERIPHERAL SWELLING (non-serious) with onset 28Jul2021 22:00, outcome "not recovered", described as "under axilla with swelling, pain also radiating to left side of breast, left side of cervical neck area.". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, peripheral swelling, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received multi-vitamins within 2 weeks of vaccination. No Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Hypersensitivity, Jarisch-Herxheimer reaction, Nervous system disorder, Sinus tachycardia
Clinical narrative: Severe central nervous system hypersensitivity; Severe central nervous system hypersensitivity; inappropriate sinus tachycardia; severe GI trauma; Jarisch-Herxheimer reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 12:15 (Lot number: ER8727) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IGG allergies to many foods" (unspecified if ongoing), notes: Known allergies: IGG allergies to many foods. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EN6205, administration date=06Mar2021, administration time=12:15 PM, dose number=1, vaccine location=Left arm), administration date: 06Mar2021, when the patient was 69 years old, for Covid-19 Immunisation. The following information was reported: HYPERSENSITIVITY (non-serious), NERVOUS SYSTEM DISORDER (non-serious) all with onset May2021, outcome "not recovered" and all described as "Severe central nervous system hypersensitivity"; SINUS TACHYCARDIA (non-serious) with onset May2021, outcome "not recovered", described as "inappropriate sinus tachycardia"; GASTROINTESTINAL DISORDER (non-serious) with onset May2021, outcome "not recovered", described as "severe GI trauma"; JARISCH-HERXHEIMER REACTION (non-serious) with onset May2021, outcome "not recovered", described as "Jarisch-Herxheimer reaction". The events "severe central nervous system hypersensitivity", "severe central nervous system hypersensitivity", "inappropriate sinus tachycardia", "severe gi trauma" and "jarisch-herxheimer reaction" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of hypersensitivity, nervous system disorder, sinus tachycardia, gastrointestinal disorder, jarisch-herxheimer reaction.  Additional information: Prior vaccination within 4 weeks was reported as none. COVID prior vaccination and COVID tested post vaccination was reported as none. Severe central nervous system hypersensitivity, inappropriate sinus tachycardia and severe GI trauma. If the research on this link: (Link).aspx proves valid it would appear that the vaccine reprogrammed my immune system to kill Candida fungus and the symptoms are due to a Jarisch-Herxheimer reaction resulting from killing the fungus to fast.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Paranasal sinus discomfort, Rhinorrhoea
Clinical narrative: Headache; severe sinus pressure on right side of face; Runny nose; Body aches; Intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 11:15 (Lot number: EW0179) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; WELLBUTRIN; BENADRYL. Vaccination history included: Bnt162b2 (lot number=EW0179, administration time=05:15 PM, dose number=1,, vaccine location=Left arm (reported as Arm Left), No events reported), administration date: 23Jul2021, when the patient was 30 years old, for Covid-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Headache"; PARANASAL SINUS DISCOMFORT (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "severe sinus pressure on right side of face"; RHINORRHOEA (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Runny nose"; PAIN (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 14Aug2021 02:00, outcome "not recovered", described as "Intense fatigue".  Additional information: Facility where the most recent covid-19 vaccine was administered was noted as doctor's office/urgent care. No name of drug was reported for relevant past drug history. Prior to vaccination, the patient was not diagnosed with covid-19 and since the vaccination, patient had not been tested for covid-19. Patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Hospitalization prolonged was noted as no. It was unknown if patient received any treatment for the events. Device date noted as 15Aug2021. Patient received Zoloft, Wellbutrin, Benadryl within 2 weeks of vaccination.    Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: Severe rash on right shin and abdomen; Severe rash on right shin and abdomen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Aug2021 10:45 (Lot number: Fc3181) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Administration Time: 10:45 AM, Vaccine location: Right Arm, Lot Number: Fa7484), administration date: 25Jul2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: RASH (non-serious), RASH (non-serious) all with onset 16Aug2021 08:00, outcome "not recovered" and all described as "Severe rash on right shin and abdomen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, rash.  Additional information: The patient had no other medical history and had no known allergies. Prior to vaccination, the patient was diagnosed with covid-19 and since the vaccination, the patient had not been tested for covid-19. List of any other medications the patient received within 2 weeks of vaccination was noted as none.  Follow-up attempts are completed. No further information is expected.