chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache (after 1st dose); Fever (after 1st dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa Drugs).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)). At the time of the report, HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications reported included unknown thyroid and Blood pressure medication. No treatment information was provided.  The patient experienced headache and fever after the first dose.   This case was linked to MOD-2021-374535, MOD-2021-374553 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Wrong dose administered; Johnson and Johnson for their first dose came in; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Wrong dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Johnson and Johnson for their first dose came in) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson for their first dose (Johnson and Johnson for their first dose came in). Past adverse reactions to the above products included No adverse event with Johnson and Johnson for their first dose.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Wrong dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Johnson and Johnson for their first dose came in). On 27-Oct-2021, INCORRECT DOSE ADMINISTERED (Wrong dose administered) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Johnson and Johnson for their first dose came in) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was taken out of freezer on 8-Sep-2021 and was administered on 22-Oct-2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot #023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant drugs are not provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Drug taken out of freezer on 9/8/2021 contains 2 vials were administered  to 12 patientsas1st dose to 1 patient,  2nd dose to 9 patients and 3rd doses (immunosuppressed) to  2 patients under no temperature exclusion.  No concomitant medications were reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient that received a dose of Moderna vaccine that expired 11/1; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no adverse event.   On 16-Oct-2021 vial was initially stored in the refrigerator.  No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Additional information includes updated reporter contact information,Added date of administration of vaccine. On 04-Nov-2021: Additional information includes Added batch/lot number,narrative was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Nausea
Clinical narrative: lumping; Pinkness; Very little appetite; flu-like symptoms; tingling; itching; nausea; tiredness; Very bad chills; Bump; Has gotten very itchy; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DECREASED APPETITE (Very little appetite) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREGABALIN (LYRICA) for Pain, CARBIDOPA, LEVODOPA (RYTARY), LOVASTATIN and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site discolouration, Vaccination site mass, Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: lumping; Pinkness; Very little appetite; flu-like symptoms; tingling; itching; nausea; tiredness; Very bad chills; Bump; Has gotten very itchy; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DECREASED APPETITE (Very little appetite) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREGABALIN (LYRICA) for Pain, CARBIDOPA, LEVODOPA (RYTARY), LOVASTATIN and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: lumping; Pinkness; Very little appetite; flu-like symptoms; tingling; itching; nausea; tiredness; Very bad chills; Bump; Has gotten very itchy; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DECREASED APPETITE (Very little appetite) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREGABALIN (LYRICA) for Pain, CARBIDOPA, LEVODOPA (RYTARY), LOVASTATIN and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), FATIGUE (tiredness), CHILLS (Very bad chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (Very little appetite), VACCINATION SITE SWELLING (Bump), VACCINATION SITE DISCOLOURATION (Pinkness), PRURITUS (itching), VACCINATION SITE PARAESTHESIA (tingling), VACCINATION SITE PRURITUS (Has gotten very itchy) and VACCINATION SITE MASS (lumping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Date the vial was initially stored in the refrigerator 24- Sept-2021. Date  of administration of vaccine 24Oct2021 - 27Oct2021 No concomitant medications was reported. no treatment was reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 49 year old patient received expired Moderna COVID-19 vaccine for his second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (49 year old patient received expired Moderna COVID-19 vaccine for his second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs are provided and treatment drugs are also not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Influenza, Pyrexia
Clinical narrative: Flu symptoms; One side of her face was burning up; Injection arm swelled up with a baseball sized lump; Injection arm lump was really really really hot to the touch; Fever of 101 degree F; Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm); Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch) and PYREXIA (Fever of 101 degree F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017P21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 30-Oct-2021, the patient experienced INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F) and VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)). At the time of the report, INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F), VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101 Degree F.         No concomitant medications provided. No treatment medications provided.  Second dose on 25Mar2021 (Lot # 008B21? , Patient can't determine the last letter).   This case was linked to MOD-2021-374785 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site rash
Clinical narrative: Flu symptoms; One side of her face was burning up; Injection arm swelled up with a baseball sized lump; Injection arm lump was really really really hot to the touch; Fever of 101 degree F; Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm); Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch) and PYREXIA (Fever of 101 degree F) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017P21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 30-Oct-2021, the patient experienced INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F) and VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)). At the time of the report, INFLUENZA (Flu symptoms), BURNING SENSATION (One side of her face was burning up), VACCINATION SITE MASS (Injection arm swelled up with a baseball sized lump), VACCINATION SITE PAIN (Injection arm lump was really really really hot to the touch), PYREXIA (Fever of 101 degree F), VACCINATION SITE RASH (Rash that was getting bigger on her injection arm (from shoulder to about mid-upper arm)) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101 Degree F.         No concomitant medications provided. No treatment medications provided.  Second dose on 25Mar2021 (Lot # 008B21? , Patient can't determine the last letter).   This case was linked to MOD-2021-374785 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that the patient received 0.5ml full third dose instead of the booster half shot on 02-Nov-2021.   This case was linked to MOD-2021-374683, MOD-2021-374919, MOD-2021-374922, MOD-2021-374933, MOD-2021-374578, MOD-2021-374706 (Patient Link).
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided. Date the vial was initially stored in the refrigerator 24Sept 2021 Date of administration of vaccine 24Oct2021 - 27Oct 2021
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after exposure to room temperature >24 hours; Dose administered after exposure to room temperature >24 hours; 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 PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours). On 14-Oct-2021, PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported Fridge's door was not closed all the way, and temperature was out of range for about 1 hour and 20 minutes, reaching a maximum of 10 degrees Celsius.   This case was linked to MOD-2021-374037 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache (after 2nd dose); Fever (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa drugs).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)). At the time of the report, HEADACHE (Headache (after 2nd dose)) and PYREXIA (Fever (after 2nd dose)) outcome was unknown.            Patient takes medication for her thyroid and blood pressure.  No treatment medication was reported   This case was linked to MOD-2021-374481, MOD-2021-374553 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Drug allergy (Lisinopril allergy).    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  This vaccine was removed from freezer on 31-Aug-2021 and was stored in a monitored refrigerator. By manufacturer guidelines, refrigerator thawed vaccine had a storage life of 30 days (29-Sep-2021) and the vaccine was administered after 29-Sep-2021.   This case was linked to MOD-2021-374588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Added Patient details and updated patient demographics. Patient's current and medical history was updated. Updated the event description in the I narrative.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Contusion, Feeling abnormal, Incorrect route of product administration, Pain in extremity
Clinical narrative: Huge bruise on her right arm; some of the solution ran down her right arm; Possibly administered subcutaneously; Right arm was sore; Felt uneasy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy), CONTUSION (Huge bruise on her right arm), ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Sulfa drugs), Thyroid disorder and Blood pressure abnormal.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy), ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously). On 03-Nov-2021, the patient experienced CONTUSION (Huge bruise on her right arm). On 01-Nov-2021, ACCIDENTAL UNDERDOSE (some of the solution ran down her right arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Possibly administered subcutaneously) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore), FEELING ABNORMAL (Felt uneasy) and CONTUSION (Huge bruise on her right arm) outcome was unknown.            Concomitant medications include thyroid medications and blood pressure medication. No treatment medications provided.   This case was linked to MOD-2021-374481, MOD-2021-374535 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased activity, Fatigue, Gait disturbance, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty) and NIGHTMARE (nightmares) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Hypothyroidism. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ENALAPRIL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), BUPRENORPHINE HYDROCHLORIDE (SUBUTEX), CLONAZEPAM (KLONOPIN), GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR), ALBUTEROL [SALBUTAMOL] and LEVOFLOXACIN (LEVOXIN) for an unknown indication.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Muscle twitching, Myalgia, Nightmare, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty) and NIGHTMARE (nightmares) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Hypothyroidism. Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Depression, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ENALAPRIL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), BUPRENORPHINE HYDROCHLORIDE (SUBUTEX), CLONAZEPAM (KLONOPIN), GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MONTELUKAST SODIUM (SINGULAIR), ALBUTEROL [SALBUTAMOL] and LEVOFLOXACIN (LEVOXIN) for an unknown indication.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), NIGHTMARE (nightmares), MUSCLE TWITCHING (jumping and twitching when they are asleep), MEMORY IMPAIRMENT (are forgetting staff too), DECREASED ACTIVITY (Loss of personal independence in daily activities), MYALGIA (Myalgia) and FATIGUE (fatigue,Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Gave 0.5ml third full dose instead of half shot booster.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-374517 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100.2 F after booster; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.2 F after booster) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 039B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.2 F after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever of 100.2 F after booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Body temperature: 100.2 f (High) Fever of 100.2 F and 99.0 f (Low) patient took a Tylenol about 20 minutes ago and his temperature is  99.0 F..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. Treatment medication reported also included Hydrate for fever.  The doctor told the patient to take 2 Tylenol and hydrate and advised them that if the temperature goes above 100.4 then get in touch with MD. Reportedly, the patient stated that they took a Tylenol about 20 minutes ago and their temperature was now 99.0 F.   This case was linked to MOD-2021-375574, MOD-2021-375559 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy; Got a rash all over the torso around legs and lower arms and face; Low fever 100.6 degrees Fahrenheit; Feeling hurt; Ached all over; Swollen lymph nodes under left arm that lasted for 2 days; Sore arm after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy), RASH (Got a rash all over the torso around legs and lower arms and face) and PYREXIA (Low fever 100.6 degrees Fahrenheit) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 042L20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Sore arm after booster dose). On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PYREXIA (Low fever 100.6 degrees Fahrenheit) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days). On 01-Nov-2021, the patient experienced PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face). At the time of the report, FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over) and PYREXIA (Low fever 100.6 degrees Fahrenheit) outcome was unknown, PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face) had not resolved and MYALGIA (Sore arm after booster dose) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-374697 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy; Got a rash all over the torso around legs and lower arms and face; Low fever 100.6 degrees Fahrenheit; Feeling hurt; Ached all over; Swollen lymph nodes under left arm that lasted for 2 days; Sore arm after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy), RASH (Got a rash all over the torso around legs and lower arms and face) and PYREXIA (Low fever 100.6 degrees Fahrenheit) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 042L20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Sore arm after booster dose). On 30-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over), PYREXIA (Low fever 100.6 degrees Fahrenheit) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days). On 01-Nov-2021, the patient experienced PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face). At the time of the report, FEELING ABNORMAL (Feeling hurt), PAIN (Ached all over) and PYREXIA (Low fever 100.6 degrees Fahrenheit) outcome was unknown, PRURITUS (Its real itchy/From elbow up all over the chest/Chest is itchy/back isn't so itchy) and RASH (Got a rash all over the torso around legs and lower arms and face) had not resolved and MYALGIA (Sore arm after booster dose) and LYMPHADENOPATHY (Swollen lymph nodes under left arm that lasted for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-374697 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Nov-2021 and was forwarded to Moderna on 03-Nov-2021.    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 (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.