chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-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) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Pharmacist gave second dose of expired vaccine which was placed in refrigerator on 07-MAY-2021 for over 30 days. Box was in fridge and they inadvertently grabbed without realizing the expiration date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered to unknown number of patients beyond to Use by date; 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 EXPIRED PRODUCT ADMINISTERED (administered to unknown number of patients beyond to Use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered to unknown number of patients beyond to Use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered to unknown number of patients beyond to Use by date) 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.   It was reported that Moderna COVID vaccine Lot#004C21A that had been received at facility and placed in the fridge on 23 Apr and some of the vaccine had been given after the 30 day refrigeration window May 24-June 4.  No concomitant product reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a nurse administers an expired dose of the Moderna COVID19 vaccine; 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 EXPIRED PRODUCT ADMINISTERED (a nurse administers an expired dose of the Moderna COVID19 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a nurse administers an expired dose of the Moderna COVID19 vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (a nurse administers an expired dose of the Moderna COVID19 vaccine) 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.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Movement disorder, Neck pain, Pain, Pyrexia
Clinical narrative: Dry mouth; needed help to move; Fever; neckache; Strong body pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN , PAIN (Strong body pain), DRY MOUTH (Dry mouth), MOVEMENT DISORDER (needed help to move) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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 01-Jun-2021, the patient experienced NECK PAIN, PAIN (Strong body pain), MOVEMENT DISORDER (needed help to move) and PYREXIA (Fever). On 10-Jun-2021, the patient experienced DRY MOUTH (Dry mouth). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, NECK PAIN and MOVEMENT DISORDER (needed help to move) outcome was unknown and PAIN (Strong body pain) and DRY MOUTH (Dry mouth) had not resolved.            No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY). At the time of the report, EXPOSURE DURING PREGNANCY (VACCINE EXPOSURE DURING PREGNANCY) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided Second dose is scheduled for 16Apr2021
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose outside the dosing window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose outside the dosing window) 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose outside the dosing window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose outside the dosing window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was reported that patient was scheduled for 2nd dose  on 01Jun2021 but was yet to receive the 2nd dose.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms). At the time of the report, INFLUENZA (Flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received the second dose and it has been more than 6 weeks since her first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it has been more than 6 weeks since her first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it has been more than 6 weeks since her first dose). On 28-Dec-2020, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose and it has been more than 6 weeks since her first 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.   Concomitant medications were not reported. Treatment details not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: I am experiencing more intense side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (I am experiencing more intense side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (I am experiencing more intense side effects). At the time of the report, ADVERSE REACTION (I am experiencing more intense side effects) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Pharmacist gave 2nd dose of expired vaccine to 6 different patients. Vaccine was placed in refrigerator on 07MAY2021 for over 30 days. They administered vaccine 15JUN2021. Box was in fridge and they inadvertently grabbed without realizing the expiration date.   This case was linked to MOD-2021-222826, MOD-2021-223023 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered a dose of moderna to a patient that had been in the fridge, punctured greater than 12 hours.; 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 EXPIRED PRODUCT ADMINISTERED (administered a dose of moderna to a patient that had been in the fridge, punctured greater than 12 hours.) 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 (administered a dose of moderna to a patient that had been in the fridge, punctured greater than 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of moderna to a patient that had been in the fridge, punctured greater than 12 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    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 AGEUSIA (Loss of taste) 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.   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(s). On an unknown date, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain, Vaccination site swelling
Clinical narrative: side effects; arm to swell after second shot; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm). At the time of the report, VACCINATION COMPLICATION (side effects), VACCINATION SITE SWELLING (arm to swell after second shot) and VACCINATION SITE PAIN (Very sore arm) outcome was unknown.            No concomitant information provided by the reporter No treatment information provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost taste buds after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste buds after 2nd dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced AGEUSIA (Lost taste buds after 2nd dose). At the time of the report, AGEUSIA (Lost taste buds after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Skin discoloration in the thumb / hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Skin discoloration in the thumb / hand) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Skin discoloration in the thumb / hand). At the time of the report, SKIN DISCOLOURATION (Skin discoloration in the thumb / hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 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 05-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 PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose of the Moderna COVID-19 vaccine) 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.   No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 2nd dose of the vaccine that was expired; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 2nd dose of the vaccine that was expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (had her first vaccine on 3/13/21 and didn't make her second appointment for the second doses) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: had a strange feeling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (had a strange feeling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (had a strange feeling). On 10-Feb-2021, FEELING ABNORMAL (had a strange feeling) had resolved.            No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Learn about severe allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Learn about severe allergic reactions) 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 HYPERSENSITIVITY (Learn about severe allergic reactions). At the time of the report, HYPERSENSITIVITY (Learn about severe allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; 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 COUGH (cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.            Treatment information was not provided by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-222917 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Covid arm questions; 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 PAIN IN EXTREMITY (Covid arm questions) 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 PAIN IN EXTREMITY (Covid arm questions). At the time of the report, PAIN IN EXTREMITY (Covid arm questions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness). At the time of the report, HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported. Treatment information was not reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node is swollen and hard; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-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 an unknown date, the patient experienced LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard). At the time of the report, LYMPHADENOPATHY (Supraclavicular lymph node is swollen and hard) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant product was reported The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   This case was linked to MOD-2021-034662 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; 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 COUGH (Cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided  It was reported that patient had experienced cough after receiving both Moderna shots and was wondering is it possible to get COVID after receiving the shot.   This case was linked to MOD-2021-222904 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO adverse event; received an expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and NO ADVERSE EVENT (NO adverse event) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (NO adverse event). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) had resolved. At the time of the report, NO ADVERSE EVENT (NO adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow up - No Adverse event experienced.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of our vaccine in DEC2020 and then second dose MAY2021; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021) 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.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: weird feeling in chest since second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (weird feeling in chest since second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (weird feeling in chest since second dose). At the time of the report, CHEST DISCOMFORT (weird feeling in chest since second dose) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment information was not provided by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling awful after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling awful after the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling awful after the 2nd dose). At the time of the report, FEELING ABNORMAL (Feeling awful after the 2nd dose) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the event was reported as not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: 2 seperate bruises; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (2 separate bruises) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (2 seperate bruises). At the time of the report, CONTUSION (2 seperate bruises) outcome was unknown.            No concomitant medications reported. No treatment information was provided. .
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) 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 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            Treatment information was not provided by reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: i feel awful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (i feel awful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (i feel awful). At the time of the report, FEELING ABNORMAL (i feel awful) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Musculoskeletal stiffness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: After 7 days, patient noticed that it spread and now she has slightly red area that is 4inchlong and 3inch wide; developed itching on upper right arm; oval shaped circle that was red on injection site; stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), ERYTHEMA (After 7 days, patient noticed that it spread and now she has slightly red area that is 4inchlong and 3inch wide), VACCINATION SITE PRURITUS (developed itching on upper right arm) and VACCINATION SITE ERYTHEMA (oval shaped circle that was red on injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included AMOXICILLIN TRIHYDRATE, BROMHEXINE HYDROCHLORIDE (BROMOLIN), CALCIUM CITRATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DOXAZOSIN, BISACODYL (DULCOLAX [BISACODYL]), FLUTICASONE PROPIONATE (FLOVENT), FLUOROURACIL, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEUCOVORIN CALCIUM, LISINOPRIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]), OXALIPLATIN, POLICOSANOL, DABIGATRAN ETEXILATE MESILATE (PRADAXA), PROCHLORPERAZINE MALEATE (COMPAZINE [PROCHLORPERAZINE MALEATE]), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), CURCUMIN, VITAMIN C [ASCORBIC ACID] and VITAMIN D3 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (developed itching on upper right arm) and VACCINATION SITE ERYTHEMA (oval shaped circle that was red on injection site). On an unknown date, the patient experienced ERYTHEMA (After 7 days, patient noticed that it spread and now she has slightly red area that is 4inchlong and 3inch wide). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), ERYTHEMA (After 7 days, patient noticed that it spread and now she has slightly red area that is 4inchlong and 3inch wide), VACCINATION SITE PRURITUS (developed itching on upper right arm) and VACCINATION SITE ERYTHEMA (oval shaped circle that was red on injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information also included ice application.   This case was linked to MOD-2021-035521 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: Lightheaded; Nauseous; Sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), NAUSEA (Nauseous) and MYALGIA (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Lightheaded), NAUSEA (Nauseous) and MYALGIA (Sore). At the time of the report, DIZZINESS (Lightheaded), NAUSEA (Nauseous) and MYALGIA (Sore) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm where i got the shot is warm; Baseball size knot on my arm; Aarm where i got the shot is very red; Arm where i got the shot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen). At the time of the report, VACCINATION SITE WARMTH (Arm where i got the shot is warm), VACCINATION SITE MASS (Baseball size knot on my arm), VACCINATION SITE ERYTHEMA (Aarm where i got the shot is very red) and VACCINATION SITE SWELLING (Arm where i got the shot is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 5 patients tested positive for covid.; 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 COVID-19 (5 patients tested positive for covid.) 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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced COVID-19 (5 patients tested positive for covid.). At the time of the report, COVID-19 (5 patients tested positive for covid.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Dizziness; Missed the recommended window between the two doses; Tiredness; Chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DIZZINESS (Dizziness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses), FATIGUE (Tiredness) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DIZZINESS (Dizziness), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses), FATIGUE (Tiredness) and CHILLS (Chills). At the time of the report, COVID-19 (COVID-19), DIZZINESS (Dizziness), FATIGUE (Tiredness) and CHILLS (Chills) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed the recommended window between the two doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) COVID test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she might Have taken Motrin for the treatment .  Patient was wondering If she waited too long for the second dose and weather or not she should repeat the first dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter's email id was added. Start date of COVID 19 was updated.