chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Influenza, Pyrexia
Clinical narrative: sweating; was kind of low for a while; flu symptoms; was cold when he went to bed; dizziness; fever/a lot of fever/fever was 101; chills; tiredness/Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed) and DIZZINESS (dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LA0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), FEELING ABNORMAL (was kind of low for a while), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), INFLUENZA (flu symptoms), FEELING COLD (was cold when he went to bed), DIZZINESS (dizziness), PYREXIA (fever/a lot of fever/fever was 101), CHILLS (chills) and FATIGUE (tiredness/Felt tired) outcome was unknown and FEELING ABNORMAL (was kind of low for a while) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever was 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-353325, MOD-2021-353320 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The vial was initially stored in the refrigerator on 13SEP2021 and was administered on 14OCT2021
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Hyperhidrosis, Influenza like illness, Nausea, Pyrexia
Clinical narrative: woke up shaking; sweating; felt kind of like the flu; could not eat anything; had a fever; was very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything) and PYREXIA (had a fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066021A, 013L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high and Lupus cystitis (She got lupus later on in life ). Concomitant products included AMLODIPINE and LOSARTAN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous). On 22-Aug-2021, TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous) had resolved.            She was prescribed with hydroxichloroquine and she chose not to take it  No Treatment Information was provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: woke up shaking; sweating; felt kind of like the flu; could not eat anything; had a fever; was very nauseous; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything) and PYREXIA (had a fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066021A, 013L20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high and Lupus cystitis (She got lupus later on in life ). Concomitant products included AMLODIPINE and LOSARTAN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous). On 22-Aug-2021, TREMOR (woke up shaking), HYPERHIDROSIS (sweating), INFLUENZA LIKE ILLNESS (felt kind of like the flu), FEEDING DISORDER (could not eat anything), PYREXIA (had a fever) and NAUSEA (was very nauseous) had resolved.            She was prescribed with hydroxichloroquine and she chose not to take it  No Treatment Information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given less than 21 days appart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart). On 03-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given less than 21 days appart) had resolved.            Concomitant information was not reported. Treatment information was not reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants was provided. No treatment medications was reported. Vaccine that had been more than 30 days in the refrigerator was given to 16 patients.   This case was linked to MOD-2021-352611 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There are no treatment or concomitant medications given.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Migraine, Off label use, Photophobia
Clinical narrative: Off label use; Migraines; Sensitive to light; Felt a brain fog; fever that came on gradually and increased in temperature for 2 days; Frontal lobe area headaches; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and PYREXIA (fever that came on gradually and increased in temperature for 2 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 031B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Obesity.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog), PYREXIA (fever that came on gradually and increased in temperature for 2 days) and HEADACHE (Frontal lobe area headaches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 mg. On 28-Sep-2021, OFF LABEL USE (Off label use) had resolved. On 03-Oct-2021, MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and HEADACHE (Frontal lobe area headaches) had resolved. At the time of the report, PYREXIA (fever that came on gradually and increased in temperature for 2 days) outcome was unknown.            No concomitant medication was provided.   Patient lied in the darkness to help with the headaches. He is not usually a person who gets migraines.   This case was linked to MOD-2021-080394, MOD-2021-080382 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Off label use; Migraines; Sensitive to light; Felt a brain fog; fever that came on gradually and increased in temperature for 2 days; Frontal lobe area headaches; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and PYREXIA (fever that came on gradually and increased in temperature for 2 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 031B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Obesity.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced OFF LABEL USE (Off label use), MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog), PYREXIA (fever that came on gradually and increased in temperature for 2 days) and HEADACHE (Frontal lobe area headaches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 500 mg. On 28-Sep-2021, OFF LABEL USE (Off label use) had resolved. On 03-Oct-2021, MIGRAINE (Migraines), PHOTOPHOBIA (Sensitive to light), FEELING ABNORMAL (Felt a brain fog) and HEADACHE (Frontal lobe area headaches) had resolved. At the time of the report, PYREXIA (fever that came on gradually and increased in temperature for 2 days) outcome was unknown.            No concomitant medication was provided.   Patient lied in the darkness to help with the headaches. He is not usually a person who gets migraines.   This case was linked to MOD-2021-080394, MOD-2021-080382 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were kept in room temperature for greater than 12 hours; Thought they had been newly drawn and administered them; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses were kept in room temperature for greater than 12 hours) and PRODUCT STORAGE ERROR (Thought they had been newly drawn and administered them) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-352687 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Pain, Sneezing
Clinical narrative: Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing; Sneezing; Not feeling the same, but also not feeling worse; has not been feeling good; Achy; Stress from not receiving Letairis; upset with Letairis shipment; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy) and STRESS (Stress from not receiving Letairis; upset with Letairis shipment) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included WARFARIN SODIUM and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 16-May-2011, the patient TREPROSTINIL SODIUM (TYVASO) (Nasal) dosage was changed to at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 started TREPROSTINIL SODIUM (TYVASO) (Nasal) microgram four times per day. In 2021, the patient experienced SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired). On 22-Sep-2021, the patient experienced DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing). At the time of the report, DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  The current dose for IH Tyvaso was reported as 18-54 µg (3-9 breaths), four times a day (QID) via inhalation (IH) route.  The patient received Flu shot(Influenza vaccine) on 22-Sep-2021
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing; Sneezing; Not feeling the same, but also not feeling worse; has not been feeling good; Achy; Stress from not receiving Letairis; upset with Letairis shipment; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy) and STRESS (Stress from not receiving Letairis; upset with Letairis shipment) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension.    Concurrent medical conditions included Secondary pulmonary arterial hypertension. Concomitant products included WARFARIN SODIUM and AMBRISENTAN (LETAIRIS) for an unknown indication.   On 16-May-2011, the patient TREPROSTINIL SODIUM (TYVASO) (Nasal) dosage was changed to at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 started TREPROSTINIL SODIUM (TYVASO) (Nasal) microgram four times per day. In 2021, the patient experienced SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired). On 22-Sep-2021, the patient experienced DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing). At the time of the report, DYSPNOEA (Trouble breathing today due to stress from not receiving Letairis yet; difficulty breathing due to being upset with Letairis shipment; difficulty breathing), SNEEZING (Sneezing), FEELING ABNORMAL (Not feeling the same, but also not feeling worse; has not been feeling good), PAIN (Achy), STRESS (Stress from not receiving Letairis; upset with Letairis shipment) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided.  The current dose for IH Tyvaso was reported as 18-54 µg (3-9 breaths), four times a day (QID) via inhalation (IH) route.  The patient received Flu shot(Influenza vaccine) on 22-Sep-2021
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Facial nerve disorder, Facial pain, Ocular discomfort, Product dose omission issue, Swelling face
Clinical narrative: not receiving 2nd dose of the Moderna COVID19 vaccine because of fear; Facial swelling/swelling that went down to her/swelled on the left side,; Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face; Left eye kept jumping/left side keeps jumping; Face is sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping), FACIAL PAIN (Face is sore) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053e21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high and High cholesterol.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping) and FACIAL PAIN (Face is sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear). At the time of the report, SWELLING FACE (Facial swelling/swelling that went down to her/swelled on the left side,), FACIAL NERVE DISORDER (Nerve issues on the left side of her face/omething with her nerves keeps jumping all over her face), OCULAR DISCOMFORT (Left eye kept jumping/left side keeps jumping) and FACIAL PAIN (Face is sore) had not resolved and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose of the Moderna COVID19 vaccine because of fear) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include high blood pressure medication and high cholesterol medication. No treatment medication was reported.  Not too long after the first dose patient started having stroke like symptoms and they have not gone away.Patient wanted to get the second dose but she was afraid.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: Sluggish; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish) and FATIGUE (Tired). At the time of the report, SLUGGISHNESS (Sluggish) and FATIGUE (Tired) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-353257 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353252, MOD-2021-353261, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593, MOD-2021-353262, MOD-2021-353249 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Little headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and MYALGIA (Muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032120A, 032120A and 050E214) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (Little headache) and MYALGIA (Muscle aches). The patient was treated with DILTIAZEM for Blood pressure, at a dose of 120 mg once a day and METOPROLOL for Blood pressure, at a dose of 25 mg twice a day. At the time of the report, HEADACHE (Little headache) and MYALGIA (Muscle aches) had resolved.            Concomitant medications were not reported .   This case was linked to MOD-2021-353234, MOD-2021-353246 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got a little bit sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (got a little bit sick) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 MALAISE (got a little bit sick). At the time of the report, MALAISE (got a little bit sick) outcome was unknown.            Concomitant medication details were not provided. Treatment details were not provided.   This case was linked to MOD21-152902 (Linked Report).; Sender's Comments:  MOD21-152902:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353241, MOD-2021-353252, MOD-2021-353261, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593, MOD-2021-353262 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: She has itching that flared up on a daily bases that she didn't have before.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She has itching that flared up on a daily bases that she didn't have before.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E214, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Polycythemia vera.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-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 PRURITUS (She has itching that flared up on a daily bases that she didn't have before.). At the time of the report, PRURITUS (She has itching that flared up on a daily bases that she didn't have before.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She was having stronger negative symptoms of polycythemia vera cancer. Concomitant medication include Blood pressure medicines. No treatment information were provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient who received a dose from a vial that was punctured more than 24 hours ago; Swelling in right arm; Pain in right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE PAIN (Pain in right arm) and EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago). In October 2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm) and VACCINATION SITE PAIN (Pain in right arm). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling in right arm) and VACCINATION SITE PAIN (Pain in right arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter has stated that patient has administered her second dose on 14-Oct-2021 at 2.05 PM. No concomitant information was reported. No treatment information was reported. Reporter has stated that the Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F and From 2:05 13-Oct-2021 to 2:53 pm 14Oct2021
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications  were reported.  No treatment information was provided.   This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353241, MOD-2021-353249, MOD-2021-353261, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593, MOD-2021-353262 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included CARVEDILOL, LOSARTAN, TRAZODONE and BUMETANIDE for an unknown indication.    On 03-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: sore left injection site arm/felt achy; tired; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 029L20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 mcg. On 18-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever). On 18-Sep-2021, VACCINATION SITE PAIN (sore left injection site arm/felt achy), FATIGUE (tired) and PYREXIA (low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-353240 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient had Covid-19 after his first Moderna Covid-19 vaccination; Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose). At the time of the report, COVID-19 (Patient had Covid-19 after his first Moderna Covid-19 vaccination) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 36 days between Moderna Covid-19 vaccinations/never received his second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.; Sender's Comments: This spontaneous case concerns a 65-year-old male patient with  no relevant medical history who experienced non serious unexpected event of special interest COVID-19. The event occurred after the first dose of Spikevax however, the exact time to onset was not provided. Reportedly, the patient had only received the first dose of Spikevax and never received the second dose. Rechallenge was not applicable since no rechallenge was done and thus, recurrence is not applicable.  The benefit-risk relationship of drug is not affected by this report. Additional event of Product dose omission issue reported since the patient never received the second dose.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment information was provided.   This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353241, MOD-2021-353249, MOD-2021-353252, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593, MOD-2021-353262 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided.   No treatment  information was provided.   This case was linked to MOD-2021-353224, MOD-2021-353228, MOD-2021-353241, MOD-2021-353249, MOD-2021-353252, MOD-2021-353261, MOD-2021-353569, MOD-2021-353578, MOD-2021-353593 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: Lymph nodes under armpit are swollen; Lymph nodes under armpit are painful; Fever/fever hasn't gone down/around 101 F; Chills; Throwing up/can't hold any food; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes under armpit are swollen), LYMPHADENOPATHY (Lymph nodes under armpit are painful), PYREXIA (Fever/fever hasn't gone down/around 101 F), CHILLS (Chills) and VOMITING (Throwing up/can't hold any food) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 939906) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PYREXIA (Fever/fever hasn't gone down/around 101 F), CHILLS (Chills) and VOMITING (Throwing up/can't hold any food). On 14-Oct-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under armpit are swollen) and LYMPHADENOPATHY (Lymph nodes under armpit are painful). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Lymph nodes under armpit are swollen), LYMPHADENOPATHY (Lymph nodes under armpit are painful) and PYREXIA (Fever/fever hasn't gone down/around 101 F) had not resolved and CHILLS (Chills) and VOMITING (Throwing up/can't hold any food) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101 (High) around 101 F.         Concomitant medication reported included hormone birth control. Treatment medication included Pepcid, and some other medication.  The patient reported that after getting the second shot, that night, the patient began to experience fever, chills and throwing up. The patient said that fever had not gone down, and it was around 101 F. The patient said that they were not able to hold any food at the moment and on 14-Oct-2021, morning, they woke up with their lymph nodes under the armpit of second shot being swollen and painful.