chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 vaccination.     The patient's past medical history included Bone marrow transplant (She had bone marrow cancer) in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced MYALGIA (sore arm). In February 2021, MYALGIA (sore arm) 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.   ice, tea and fluids were treatment medications. No concomitant medication was reported. Reporter reported that she had bone marrow cancer.   This case was linked to MOD-2021-320894, MOD-2021-320895 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flushing, Sleep disorder, Vaccination site swelling
Clinical narrative: felt really rough like she was trying to shake the flu, like a truck ran over her; felt flushed; shoulder woke her up when she rolled on it; left shoulder became very swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed), SLEEP DISORDER (shoulder woke her up when she rolled on it) and VACCINATION SITE SWELLING (left shoulder became very swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A. and 020L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (bone marrow cancer) in 2007 and Bone marrow transplant in 2007.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (left shoulder became very swollen). On 15-Sep-2021, the patient experienced FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed) and SLEEP DISORDER (shoulder woke her up when she rolled on it). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing from 15-Sep-2021 for Sleep difficult, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt really rough like she was trying to shake the flu, like a truck ran over her), FLUSHING (felt flushed), SLEEP DISORDER (shoulder woke her up when she rolled on it) and VACCINATION SITE SWELLING (left shoulder became very swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The night of the vaccination, her shoulder became very swollen and she iced it. She drank tea and fluids for adverse events.   This case was linked to MOD-2021-320894, MOD-2021-320886.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Interchange of vaccine products
Clinical narrative: Administration date of Moderna vaccine past the BUD; previously received 1 dose of a non-WHO approved vaccine (Convidecia); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INTERCHANGE OF VACCINE PRODUCTS (previously received 1 dose of a non-WHO approved vaccine (Convidecia)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.   This case was linked to MOD-2021-320876 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to the company on 16-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 3:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)) 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. Consumer was administered a dose out of a vial that was left out the fridge for more than 24 hours. The dose was administered on 16Sep2021. Not known if it is patient's 1st or 2nd dose. Healthcare provider (HCP), a pharmacist states that a patient has been administered with the vaccine today, 16Sep2021 (3:45pm)  from a vial that was first punctured on 15Sep2021 (10:15am) with lot number 014F21A.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received on 16 Sep 2021 contains reporter, patient information and dose information
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Lethargy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and FATIGUE (Tiredness) 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 LETHARGY (Lethargy) and FATIGUE (Tiredness). At the time of the report, LETHARGY (Lethargy) and FATIGUE (Tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-321164 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Nausea, Pyrexia
Clinical narrative: upset stomach; light fever; feeling nausea; having chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), PYREXIA (light fever), NAUSEA (feeling nausea) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series). On 16-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (More than 35 days since the first dose without taking a second dose/Got a dose of the Johnson&Johnson vaccine/patient received mixed series) 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. The patient second dose of Johnson&johnson vaccine on 16-Sep-2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired (first dose); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired (first dose)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hidradenitis suppurativa (Patient has a immune condition). Concomitant products included DOXYCYCLINE for Hidradenitis suppurativa.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FATIGUE (tired (first dose)). At the time of the report, FATIGUE (tired (first dose)) outcome was unknown.        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.   This case was linked to MOD-2021-321025 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Weight decreased
Clinical narrative: Diarrhea for the past 2 weeks; Food is not sitting in my stomach, can't hold down food; Lost weight, I'm probably about 160 lbs; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided by reporter.     On 03-Sep-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 DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea for the past 2 weeks), ABDOMINAL DISCOMFORT (Food is not sitting in my stomach, can't hold down food) and WEIGHT DECREASED (Lost weight, I'm probably about 160 lbs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Other treatment medication include Ginger ale
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dysstasia, Product dose omission issue
Clinical narrative: Weak/After 1st dose she was down for 10 days/She totally failed for 10 days; Dizzy; Joints hurt all over; Couldn't stand; She further stated that she did not take the 2nd dose due to her side effects.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.). At the time of the report, ASTHENIA (Weak/After 1st dose she was down for 10 days/She totally failed for 10 days), DIZZINESS (Dizzy), ARTHRALGIA (Joints hurt all over), DYSSTASIA (Couldn't stand) and PRODUCT DOSE OMISSION ISSUE (She further stated that she did not take the 2nd dose due to her side effects.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose expired 13Sep2021 at 1 AM; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose expired 13Sep2021 at 1 AM) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose expired 13Sep2021 at 1 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose expired 13Sep2021 at 1 AM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  The vaccine was first punctured on 13-Sep-2021 at 1 PM, so it should have expired twelve hours later. The vaccine was administered to the patient on 16-Sep-2021.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage girl got the first Moderna dose/17 year old getting the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine). On 16-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage girl got the first Moderna dose/17 year old getting the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were provided. No Treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non Significant Follow Up received on 16-SEP- 2021 contains no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    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 PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-320984, MOD-2021-307848 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Urticaria
Clinical narrative: itchy; hives on 1st; missed dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on 1st), PRODUCT DOSE OMISSION ISSUE (missed dose) and PRURITUS (itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ATORVASTATIN for Cholesterol, METRONIDAZOLE for Rosacea, GABAPENTIN, DIETHYLSTILBESTROL (OESTROGEN), COLECALCIFEROL (VITAMIN D3), MAGNESIUM, ALLIUM SATIVUM, CAPSICUM ANNUUM, CRATAEGUS LAEVIGATA, FOENICULUM VULGARE, UBIDECARENONE (HEART), ZINC and ACETYLCYSTEINE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (hives on 1st). 22-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). On an unknown date, the patient experienced PRURITUS (itchy). On 10-Apr-2021, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved. At the time of the report, URTICARIA (hives on 1st) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.   This case was linked to MOD-2021-321111 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: syringe got leaked and patient was administered less than half of the dose; syringe got leaked and patient was administered less than half of the dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose). At the time of the report, DEVICE CONNECTION ISSUE (syringe got leaked and patient was administered less than half of the dose) and UNDERDOSE (syringe got leaked and patient was administered less than half of the dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were  reported. No Treatment medications  were  reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeding disorder, Illness, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Extremely ill; Diarrhea; Could not eat, Could not drink anything; first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Inflammation (Taking Ilaris (Biologic Medicine) for inflammation. She has a gene that causes inflammation). Concomitant products included CANAKINUMAB (ILARIS) for Inflammation.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting). On 11-Mar-2021, ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything) and VOMITING (Vomiting) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) She states that she did not contact her doctor..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  She states that she is afraid of taking the second dose.  Consent received for safety to follow up with the patient (Prefers Email).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extremely ill; Diarrhea; Could not eat, Could not drink anything; first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Inflammation (Taking Ilaris (Biologic Medicine) for inflammation. She has a gene that causes inflammation). Concomitant products included CANAKINUMAB (ILARIS) for Inflammation.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting). On 11-Mar-2021, ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything) and VOMITING (Vomiting) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) She states that she did not contact her doctor..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  She states that she is afraid of taking the second dose.  Consent received for safety to follow up with the patient (Prefers Email).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Feeling hot, Somnolence
Clinical narrative: Her leg is also hot to touch; Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear; She began sleeping all day, only getting up to drink water.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (She began sleeping all day, only getting up to drink water.), BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear) and FEELING HOT (Her leg is also hot to touch) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 059E21A) for COVID-19 vaccination.     The patient's past medical history included Fatigue (No history of cardiac problems Cardiac related signs and symptoms: Fatigue). Concurrent medical conditions included Seizure (She had 2 shunts in her head that drain into her stomach.), Fibromatosis and Neurological disorder NOS (She had an extreme neurological disorder.They said she wouldn't live past 5 years old.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (She began sleeping all day, only getting up to drink water.). On 14-Sep-2021, the patient experienced BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear). On 16-Sep-2021, the patient experienced FEELING HOT (Her leg is also hot to touch). At the time of the report, SOMNOLENCE (She began sleeping all day, only getting up to drink water.), BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear) and FEELING HOT (Her leg is also hot to touch) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Covid-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19). The patient was treated with IBUPROFEN (oral) at a dose of one tablet by mouth every 6 hours. On 16-May-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient was given a transfusion for Covid antibodies in a facility on 26 May 2021 and felt better after 24 hours of the transfusion.  Company comment: This case concerns a 52 year-old female patient with no reported history who experienced the unexpected event of SARS-CoV-2 test: positive. The event occurred approximately 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was downgraded for seriousness criteria.   This case was linked to MOD-2021-321059.; Sender's Comments: This case concerns a 52 year-old female patient with no reported history who experienced the unexpected event of SARS-CoV-2 test: positive. The event occurred approximately 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was downgraded for seriousness criteria.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after second dose of vaccine). At the time of the report, HEADACHE (Headache after second dose of vaccine) outcome was unknown.      No concomitant drug details were reported. No treatment details were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: has previously received 1 dose of AstraZeneca; Administration date of Moderna vaccine past the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE ASTRAZENECA.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (has previously received 1 dose of AstraZeneca) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported. It was reported that 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21.   This case was linked to MOD-2021-320876 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Feeling cold, Hyperhidrosis, Mobility decreased, Paralysis
Clinical narrative: He has not had any symptoms since this episode of paralysis; Started to sweat; Couldn't move at all for 30 minutes; He tried to scoot off the bed and go to bathroom but ended up on the floor; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (He has not had any symptoms since this episode of paralysis) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) (Pacemaker). Concurrent medical conditions included Anaemia and Autoimmune disorder.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced PARALYSIS (He has not had any symptoms since this episode of paralysis) (seriousness criterion medically significant), HYPERHIDROSIS (Started to sweat), MOBILITY DECREASED (Couldn't move at all for 30 minutes), FALL (He tried to scoot off the bed and go to bathroom but ended up on the floor) and FEELING COLD (Felt cold). On 25-Aug-2021, PARALYSIS (He has not had any symptoms since this episode of paralysis), HYPERHIDROSIS (Started to sweat), MOBILITY DECREASED (Couldn't move at all for 30 minutes), FALL (He tried to scoot off the bed and go to bathroom but ended up on the floor) and FEELING COLD (Felt cold) had resolved.            No concomitant medication was given. No treatment medication was given.  Company Comment: A 75-year-old male, with pacemaker, presented with serious unexpected paralysis, and non-serious hyperhidrosis, mobility decreased, fall and feeling cold. Latency 224 days after first dose, 197 days after second dose, and 1 day after third dose. Events resolved. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 75-year-old male, with pacemaker, presented with serious unexpected paralysis, and non-serious hyperhidrosis, mobility decreased, fall and feeling cold. Latency 224 days after first dose, 197 days after second dose, and 1 day after third dose. Events resolved. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Peripheral swelling, Pruritus, Skin mass
Clinical narrative: Feeling a little more sluggish and tired than usual; Feeling a little more sluggish and tired than usual; Started itching; Fever came back in the area; Redness; knot- it feels thick; And spreading and covers 4top to bottom x 6inches front to back of the upper arm; Red; Knot- thickness; The area was feverish; Spread out to a size of 2 top to bottomx4 front to back inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish), PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) and PRURITUS (Started itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches). On 11-Sep-2021, the patient experienced PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick) and PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm). On 16-Sep-2021, the patient experienced SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual). On 09-Sep-2021, ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) had resolved. At the time of the report, PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick), PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm), SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual) 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.   Patient usually has reactions to flu shots, bee stings.  No Concomitant medication were reported. No treatment medication were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site warmth
Clinical narrative: Feeling a little more sluggish and tired than usual; Feeling a little more sluggish and tired than usual; Started itching; Fever came back in the area; Redness; knot- it feels thick; And spreading and covers 4top to bottom x 6inches front to back of the upper arm; Red; Knot- thickness; The area was feverish; Spread out to a size of 2 top to bottomx4 front to back inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish), PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) and PRURITUS (Started itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches). On 11-Sep-2021, the patient experienced PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick) and PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm). On 16-Sep-2021, the patient experienced SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual). On 09-Sep-2021, ERYTHEMA (Red), SKIN MASS (Knot- thickness), VACCINATION SITE WARMTH (The area was feverish) and PERIPHERAL SWELLING (Spread out to a size of 2 top to bottomx4 front to back inches) had resolved. At the time of the report, PRURITUS (Started itching), VACCINATION SITE WARMTH (Fever came back in the area), ERYTHEMA (Redness), SKIN MASS (knot- it feels thick), PERIPHERAL SWELLING (And spreading and covers 4top to bottom x 6inches front to back of the upper arm), SLUGGISHNESS (Feeling a little more sluggish and tired than usual) and FATIGUE (Feeling a little more sluggish and tired than usual) 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.   Patient usually has reactions to flu shots, bee stings.  No Concomitant medication were reported. No treatment medication were reported.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had covid after taking vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had covid after taking vaccine) in a 96-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.    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 COVID-19 (Had covid after taking vaccine). At the time of the report, COVID-19 (Had covid after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported No treatment Drug was reported
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: one of the clinics gave an underage girl the first Moderna dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3rd dose from a vial punctured over a week ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to the company on 16-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.    On 16-Sep-2021 at 8:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3rd dose from a vial punctured over a week ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   vial was first punctured on 09-Sep-2021 at 1.18 PM& after that it was stored in fridgeThe time of minimal exposure of dose was drawn up. No concomitant medication was reported by reporter No treatment medications were reported by reporter