chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: period type Nausea feeling; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (period type Nausea feeling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid infection, Anxiety, Hypertension, Asthma and Penicillin allergy.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (period type Nausea feeling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, NAUSEA (period type Nausea feeling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-364745 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: vaccine overdose as someone received full dose versus half dose/received 3rd dose as a booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (vaccine overdose as someone received full dose versus half dose/received 3rd dose as a booster) 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 ACCIDENTAL OVERDOSE (vaccine overdose as someone received full dose versus half dose/received 3rd dose as a booster). At the time of the report, ACCIDENTAL OVERDOSE (vaccine overdose as someone received full dose versus half dose/received 3rd dose as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Discomfort
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of cardiac disorder (a little bit of complication with their heart/pretty horrendous heart episode) and discomfort (it was uncomfortable) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 010M20A and 013L20A) for COVID-19 immunization. The patient's past medical history included sickness (in Jan 2021 patient was pretty sick; thought it might be COVID-19; but by the time they tested, the result was negative). Concurrent medical conditions included asthma, diabetes and atrial fibrillation. On Jan 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cardiac disorder (a little bit of complication with their heart/pretty horrendous heart episode) and discomfort (it was uncomfortable). At the time of the report, cardiac disorder (a little bit of complication with their heart/pretty horrendous heart episode) and discomfort (it was uncomfortable): resolving. Treatment medication included steroids, a Z-pack and antibiotics. Patient put on steroids from Jan 2021 till Feb 2021. No concomitant medication reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm is a little bit sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. January 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient experienced pain in extremity (arm is a little bit sore). At the time of the report, pain in extremity (arm is a little bit sore) resolved. No concomitant medication or treatment information reported. Reportedly, patient also had some blood in urine after booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a few patients given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a few patients given expired 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 EXPIRED PRODUCT ADMINISTERED (a few patients given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a few patients given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received booster dose from expired vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received booster dose from expired vial) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) 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 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. They moved the vial from the freezer to the refrigerator on 18-Oct-2021 and administered it to 12 patients today. It was not know if these were the patients' 1st or 2nd doses.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter stated that no adverse reactions have been reported by patient from the 3rd dose. Reporter stated that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. Patient was given full 3rd dose of the Moderna COVID-19 vaccine.   This case was linked to MOD-2021-364220, MOD-2021-364234  , MOD-2021-364264  , MOD-2021-364651  , MOD-2021-364672  , MOD-2021-364689  , MOD-2021-364712  , MOD-2021-364761  , MOD-2021-364787, MOD-2021-364818  , MOD-2021-365038  , MOD-2021-364953  , MOD-2021-364958  , MOD-2021-364993  , MOD-2021-365049  , MOD-2021-365054  , MOD-2021-365065  , MOD-2021-365098  , MOD-2021-365191 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Some chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Some chills) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis and Blood pressure.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHILLS (Some chills) and FATIGUE (Fatigue). In February 2021, CHILLS (Some chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included medications for Blood pressure and Multiple sclerosis. No treatment was received for symptoms.   This case was linked to MOD-2021-364929 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Muscular weakness
Clinical narrative: Lost almost all control of her muscles; She can barely stand; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 029A21A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis and Blood pressure high.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand). At the time of the report, MUSCULAR WEAKNESS (Lost almost all control of her muscles) and DYSSTASIA (She can barely stand) outcome was unknown.            Unknown concomitant medications were reported for Blood pressure and Multiple sclerosis Treatment information was not provided.   This case was linked to MOD-2021-364915 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to a patient). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date when the vial was initially stored in the refrigerator was 24-Oct-2021  The vial did not undergo any temperature excursions.  No concomitant medication reported. No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was kept in the refrigerator since 08-Oct-2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: My arm is causing me a lot of pain./My left arm was hurting; Patient recived first vaccine on 28-Apr and second vaccine on 16-May; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00K21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May). On 16-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        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.  It was reported that doses were administered to 20 patients from these expired vials .  The vials expired on 8OCT2021 and were left in the refrigerator past that date. All 20 patients were given the full 3rd dose of the Moderna COVID-19 vaccine as it was a clinic for immunocompromised patients Caller states that no adverse reactions have been reported by any patients from the 3rd dose.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Low-grade fever of a 100 F; Headache; The right arm is hurting at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 013M20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site). At the time of the report, PYREXIA (Low-grade fever of a 100 F), HEADACHE (Headache) and VACCINATION SITE PAIN (The right arm is hurting at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Body temperature 100F.         Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Wrong technique in device usage process
Clinical narrative: outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial); Off label use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use) 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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (outside of protocol (booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial)) and OFF LABEL USE (Off label use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Patients may had received booster dose that were drawn first with a larger syringe and then drawn from the syringe to avoid more than 20 punctures of the vial.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose as a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Date the vial was initially stored in the refrigerator: 26-Oct-2021. The vial did not undergo any temperature excursions.   This case was linked to MOD-2021-365107 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Covid infection after completing primary vaccination series; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series) 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 EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series). At the time of the report, EXPOSURE TO SARS-COV-2 (Covid infection after completing primary vaccination series) outcome 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 use was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine expired and administered to a patient) and product storage error (vial open for over 12 hours, 22 and a half hours) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 035C21A) for COVID-19 immunization. No medical history reported. On Oct 21, 2021, at 11:40, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Oct 21, 2021, patient administered expired product (vaccine expired and administered to a patient) and product storage error (vial open for over 12 hours, 22 and a half hours). On Oct 21, 2021, administered expired product (vaccine expired and administered to a patient) and product storage error (vial open for over 12 hours, 22 and a half hours) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vial initially stored in refrigerator on Oct 20, 2021 and first punctured on Oct 20, 2021 around 12 pm. The vial did not undergone any temperature excursions. The reporter stated the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for around 1 hour.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal chest pain, Spinal pain
Clinical narrative: Pain under the ribs; Pain around the back side; Pain around the C4 & C5 vertebrae; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003C21A) 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 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae) had not resolved.            Concomitant medications were not provided It was unknown if the dose was given into the left or right deltoid. Patient visited doctor including a pain management physician and a neurologist. It was reported that she received unknown injections for treatment. The reporter stated that the patient has had ongoing pain since April 2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Night sweats, Pyrexia
Clinical narrative: I couldn't even move tired; she was "ringing wet" that night; fever; very very tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired). On 03-Mar-2021, MOBILITY DECREASED (I couldn't even move tired), NIGHT SWEATS (she was "ringing wet" that night), PYREXIA (fever) and FATIGUE (very very tired) had resolved.            No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-364859 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Administration site movement impairment, Limb discomfort, Muscular weakness, Vaccination site mass
Clinical narrative: Lump on the injection site (1-1.5") after first shot; Pain  left arm on Movement after first shot; Uncomfortable to move the left arm after first shot; Left arm is a little weaker after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot). At the time of the report, VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that when he moves the left arm he has awareness that the lump is there. Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (really tired). On 04-Jan-2021, FATIGUE (really tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she took a high protein meal and felt better.   Concomitant medication were not reported.   This case was linked to MOD-2021-365027 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: got third full dose by mistake and not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (got third full dose by mistake and not immunocompromised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 EXTRA DOSE ADMINISTERED (got third full dose by mistake and not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (got third full dose by mistake and not immunocompromised) had resolved.            No concomitant medications were provided.   No treatment medications were provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness ( 1 hour after vaccine); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness ( 1 hour after vaccine)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (dizziness ( 1 hour after vaccine)). At the time of the report, DIZZINESS (dizziness ( 1 hour after vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) 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. The reporter reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. The vials expired on 08-Oct-2021 and were left in the refrigerator past that date. The full 3rd dose of the Moderna COVID-19 vaccine as it was a clinic for immunocompromised patients.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Slight reaction to the first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine) in a 96-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: Flu shot (patient received the flu shot 2months ago and had a pretty bad reaction to the flu shot where she had fever, aches, pain and leg weakness and stated that she can hardly walk and stated that it was major.) in 2021. Past adverse reactions to the above products included Adverse reaction to product with Flu shot. Concurrent medical conditions included Blood pressure, Cancer and Thyroid disorder.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (Slight reaction to the first dose of moderna vaccine) had resolved.            Concomitant medication includes 20 medications for blood pressure, cancer, and thyroid.  Eevnt was minor and lasted a day or two and was better.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Arm was extremely sore; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Anxiety. Concomitant products included CLONAZEPAM for Anxiety, SIMVASTATIN for Blood cholesterol abnormal, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) and LISINOPRIL for Blood pressure abnormal, VITAMIN D3 and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Arm was extremely sore), NAUSEA (nausea) and HEADACHE (slight headache) had not resolved.            The patient did not receive any corrective treatment for all the events.  The patient's current symptoms were ongoing but had calm down a bit.   This case was linked to MOD-2021-365030, MOD-2021-365056 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a Manager of Pharmacy Operations for doctor's offices.   Concomitant medication of the patient was not reported.  The reporter reported that 2 vials of the Moderna COVID-19 vaccine were left in the refrigerator past their use by date. Doses were administered to 20 patients from these expired vials. The vials expired on 08-Oct-2021 and were left in the refrigerator past that date. The reporter reported that that no adverse reactions had been reported by the patient from the 3rd dose.  No treatment information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: My whole body was hurting and; Had slight headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Oct-2021 and was forwarded to Moderna on 26-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (My whole body was hurting and) and HEADACHE (Had slight headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 013M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Anxiety. Concomitant products included CLONAZEPAM for Anxiety, BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) and LISINOPRIL for Blood pressure abnormal, SIMVASTATIN for Cholesterol, VITAMIN D3 and CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced PAIN (My whole body was hurting and) and HEADACHE (Had slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 dosage form. At the time of the report, PAIN (My whole body was hurting and) and HEADACHE (Had slight headache) was resolving.            This case was linked to MOD-2021-365051 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza like illness, Lymph node pain, Pain
Clinical narrative: flu like; achiness; lymph nodes feel sore all over; joint pain; headache; feels feverish/slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature) outcome was unknown.            No concomitant medication were reported. She took an Excedrin last night and felt some better.   This case was linked to MOD-2021-365061, MOD-2021-364147 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like; achiness; lymph nodes feel sore all over; joint pain; headache; feels feverish/slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like), PAIN (achiness), LYMPH NODE PAIN (lymph nodes feel sore all over), ARTHRALGIA (joint pain), HEADACHE (headache) and PYREXIA (feels feverish/slightly elevated temperature) outcome was unknown.            No concomitant medication were reported. She took an Excedrin last night and felt some better.   This case was linked to MOD-2021-365061, MOD-2021-364147 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration 07-may-2021  No concomitant medication was reported   No treatment medication was reported
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.). On 28-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the other two doses were given somewhere else and can't confirm if they were intramuscular injections or not.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-365085, MOD-2021-364970 (Patient Link).