chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Dyspnoea, Muscle spasms, Palpitations
Clinical narrative: Feeling pain in chest around heart; Kind of spasm; Very unconformable; Very rapid heart beat; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Allergy.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath). At the time of the report, CHEST PAIN (Feeling pain in chest around heart), MUSCLE SPASMS (Kind of spasm), DISCOMFORT (Very unconformable), PALPITATIONS (Very rapid heart beat) and DYSPNOEA (Shortness of breath) 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.   Patient took Tylenol to reduce pain. Patient use to carry Epi pen along.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: Pain up my arm - left arm; Pain on my neck - left side; Discomfort in my neck - left side; Both arms hurt; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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 PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt). At the time of the report, PAIN IN EXTREMITY (Pain up my arm - left arm), NECK PAIN (Pain on my neck - left side), MUSCULOSKELETAL DISCOMFORT (Discomfort in my neck - left side) and PAIN IN EXTREMITY (Both arms hurt) 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 Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-062273, MOD21-062330 (E2B Linked Report).; Sender's Comments:  MOD21-062273:Linked to 2nd dose MOD-2021-057753 MOD21-062330:cross linked
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: itchy; like pain; hot to the touch; big red welt at the injection site; Started to get red the same day of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (like pain), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE URTICARIA (big red welt at the injection site) and VACCINATION SITE ERYTHEMA (Started to get red the same day of the injection) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Cold burn, Dizziness, Dyspnoea, Pharyngeal paraesthesia
Clinical narrative: sharp dizziness; cold burning flesh feeling; trouble breathing; throat was tingly; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (sharp dizziness), COLD BURN (cold burning flesh feeling), DYSPNOEA (trouble breathing) and PHARYNGEAL PARAESTHESIA (throat was tingly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Hives.  relevant concomitant products usage were not reported by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (sharp dizziness), COLD BURN (cold burning flesh feeling), DYSPNOEA (trouble breathing) and PHARYNGEAL PARAESTHESIA (throat was tingly). At the time of the report, DIZZINESS (sharp dizziness), COLD BURN (cold burning flesh feeling), DYSPNOEA (trouble breathing) and PHARYNGEAL PARAESTHESIA (throat was tingly) outcome was unknown.    No treatment information was provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu like reaction; not feel good; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 2001 and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery since an unknown date and Angina attack.   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 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good). On 26-Feb-2021, INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good) 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   This case was linked to US-MODERNATX, INC.-MOD-2021-057879 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057879:Case for second dose
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive; Running nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose) and SARS-COV-2 TEST POSITIVE (Covid-19 positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RHINORRHOEA (Running nose). On 25-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 positive). At the time of the report, RHINORRHOEA (Running nose) and SARS-COV-2 TEST POSITIVE (Covid-19 positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Myalgia, Nausea, Pyrexia
Clinical narrative: Sick; Stomach upset; Bodyaches; Fever; Nauseated; Episodes of vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever) and NAUSEA (Nauseated) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever), NAUSEA (Nauseated) and VOMITING (Episodes of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever), NAUSEA (Nauseated) and VOMITING (Episodes of vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sick; Stomach upset; Bodyaches; Fever; Nauseated; Episodes of vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever) and NAUSEA (Nauseated) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever), NAUSEA (Nauseated) and VOMITING (Episodes of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, ILLNESS (Sick), ABDOMINAL DISCOMFORT (Stomach upset), MYALGIA (Bodyaches), PYREXIA (Fever), NAUSEA (Nauseated) and VOMITING (Episodes of vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bladder pain, Body temperature, Fatigue, Feeding disorder
Clinical narrative: Worsened fatigue; Inability to eat; Pain in her bladder; Foul smelling urine; Arthritis worsened; Knees were swollen; Vaccine site bruise; hypotension; Fever of 100.4; Reoccurring headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine) and ARTHRITIS (Arthritis worsened) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Influenza (severe connective tissue disease flare) in 2020. Concurrent medical conditions included Clotting disorder since 2004, Sleep apnea since 1996, Degenerative joint disease (Worsening) since 1976 and Neurological disorder NOS (intermittent symptomatic worsening) since 2019. Concomitant products included WARFARIN for Clotting disorder, CANDESARTAN from an unknown date to 07-Mar-2021 for Hypertension, FOLINIC ACID and METHYLCOBALAMIN for Neurological disorder NOS.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), JOINT SWELLING (Knees were swollen), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache). At the time of the report, FATIGUE (Worsened fatigue) and JOINT SWELLING (Knees were swollen) was resolving and FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever at 100.4. On 06-Mar-2021, International normalised ratio: 5.4 (High) INR went up to 5.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-058249.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: F/u received on 24-MAY-2021 , patient demographic details was updated, patient medical history was updated , events was updated, concomitant medications was updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypotension, International normalised ratio, Joint swelling, Pyrexia
Clinical narrative: Worsened fatigue; Inability to eat; Pain in her bladder; Foul smelling urine; Arthritis worsened; Knees were swollen; Vaccine site bruise; hypotension; Fever of 100.4; Reoccurring headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine) and ARTHRITIS (Arthritis worsened) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Influenza (severe connective tissue disease flare) in 2020. Concurrent medical conditions included Clotting disorder since 2004, Sleep apnea since 1996, Degenerative joint disease (Worsening) since 1976 and Neurological disorder NOS (intermittent symptomatic worsening) since 2019. Concomitant products included WARFARIN for Clotting disorder, CANDESARTAN from an unknown date to 07-Mar-2021 for Hypertension, FOLINIC ACID and METHYLCOBALAMIN for Neurological disorder NOS.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), JOINT SWELLING (Knees were swollen), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache). At the time of the report, FATIGUE (Worsened fatigue) and JOINT SWELLING (Knees were swollen) was resolving and FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever at 100.4. On 06-Mar-2021, International normalised ratio: 5.4 (High) INR went up to 5.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-058249.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: F/u received on 24-MAY-2021 , patient demographic details was updated, patient medical history was updated , events was updated, concomitant medications was updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal, Vaccination site bruising
Clinical narrative: Worsened fatigue; Inability to eat; Pain in her bladder; Foul smelling urine; Arthritis worsened; Knees were swollen; Vaccine site bruise; hypotension; Fever of 100.4; Reoccurring headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine) and ARTHRITIS (Arthritis worsened) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Influenza: Influenza (severe connective tissue disease flare) in 2020. Concurrent medical conditions included Clotting disorder since 2004, Sleep apnea since 1996, Degenerative joint disease (Worsening) since 1976 and Neurological disorder NOS (intermittent symptomatic worsening) since 2019. Concomitant products included WARFARIN for Clotting disorder, CANDESARTAN from an unknown date to 07-Mar-2021 for Hypertension, FOLINIC ACID and METHYLCOBALAMIN for Neurological disorder NOS.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Worsened fatigue), FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), JOINT SWELLING (Knees were swollen), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache). At the time of the report, FATIGUE (Worsened fatigue) and JOINT SWELLING (Knees were swollen) was resolving and FEEDING DISORDER (Inability to eat), BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Foul smelling urine), ARTHRITIS (Arthritis worsened), VACCINATION SITE BRUISING (Vaccine site bruise), HYPOTENSION (hypotension), PYREXIA (Fever of 100.4) and HEADACHE (Reoccurring headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever at 100.4. On 06-Mar-2021, International normalised ratio: 5.4 (High) INR went up to 5.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-058249.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: F/u received on 24-MAY-2021 , patient demographic details was updated, patient medical history was updated , events was updated, concomitant medications was updated.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue, Vaccination site pain
Clinical narrative: soreness for about three days at the injection site; discolored vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (soreness for about three days at the injection site) and PRODUCT COLOUR ISSUE (discolored vaccine) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT COLOUR ISSUE (discolored vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness for about three days at the injection site). On 03-Feb-2021, PRODUCT COLOUR ISSUE (discolored vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness for about three days at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.  The patient had soreness for about three days at the injection site.   This case was linked to MOD-2021-034060 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up information included Event of soreness at injection site from FU1 and  updated the action taken, dechallenge and rechallenge. Dose 2 case number was linked.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash, Rash erythematous
Clinical narrative: itching of the right hand; rash on right hand; red and painful rash from neck to abdomen including arms; on and off headaches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching of the right hand), RASH (rash on right hand), RASH ERYTHEMATOUS (red and painful rash from neck to abdomen including arms) and HEADACHE (on and off headaches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and HYDROCORTISONE.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced PRURITUS (itching of the right hand), RASH (rash on right hand), RASH ERYTHEMATOUS (red and painful rash from neck to abdomen including arms) and HEADACHE (on and off headaches). At the time of the report, PRURITUS (itching of the right hand), RASH (rash on right hand), RASH ERYTHEMATOUS (red and painful rash from neck to abdomen including arms) and HEADACHE (on and off headaches) outcome was unknown.            This case was linked to MOD-2021-044888, MOD-2021-044888 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Swelling, Tenderness
Clinical narrative: swollen; hard; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch). At the time of the report, SWELLING (swollen), INDURATION (hard) and TENDERNESS (tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash erythematous, Rash pruritic
Clinical narrative: Raised blisters; Skin eruptions on both arms/ Red patches under skin; Skin eruptions on both arms/ Itch/ red patches under skin; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included XANTOFYL, ZEAXANTHIN (LUTEIN ZEAXANTHIN) for Macula abnormality, FINASTERIDE for Prostate tenderness, METFORMIN, INSULIN LISPRO, IRBESARTAN, AMLODIPINE BESYLATE, ATORVASTATIN, CHROMIUM PICOLINATE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin). At the time of the report, BLISTER (Raised blisters), RASH ERYTHEMATOUS (Skin eruptions on both arms/ Red patches under skin) and RASH PRURITIC (Skin eruptions on both arms/ Itch/ red patches under skin) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   other concomitant medications include Insulin Lantus 30 units and vitamin D 5000 IU. treatment included antibiotic cream and eucerin cream.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: menstrual headache; Rash in the injection site left arm; Redness around injection site; Warm to the touch around injection site; Itchy around injection siite; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite), VACCINATION SITE RASH (Rash in the injection site left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and HEADACHE (menstrual headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 28-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash in the injection site left arm). On an unknown date, the patient experienced HEADACHE (menstrual headache). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection siite), VACCINATION SITE RASH (Rash in the injection site left arm), VACCINATION SITE ERYTHEMA (Redness around injection site) and HEADACHE (menstrual headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporterTreatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up information received on 31 Mar 2021.Added new event. On 12-May-2021: Follow-up information received on 12 May 2021.Added reporter email address.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Muscular weakness, Pruritus, Tenderness
Clinical narrative: It itched a little; tender to touch; weakness in my hands; as the day progress it gets worse; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It itched a little), TENDERNESS (tender to touch), DIZZINESS (dizzy), MUSCULAR WEAKNESS (weakness in my hands) and CONDITION AGGRAVATED (as the day progress it gets worse) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (dizzy). On an unknown date, the patient experienced PRURITUS (It itched a little), TENDERNESS (tender to touch), MUSCULAR WEAKNESS (weakness in my hands) and CONDITION AGGRAVATED (as the day progress it gets worse). At the time of the report, PRURITUS (It itched a little), TENDERNESS (tender to touch), DIZZINESS (dizzy), MUSCULAR WEAKNESS (weakness in my hands) and CONDITION AGGRAVATED (as the day progress it gets worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: bruising at the injection site; heat at the injection site; redness at the injection site; itching at the injection site; soreness at the injection site; headache; swelling at the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache), FATIGUE (tiredness), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and FATIGUE (tiredness). On 21-Mar-2021, the patient experienced VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On 21-Mar-2021, HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: bruising at the injection site; heat at the injection site; redness at the injection site; itching at the injection site; soreness at the injection site; headache; swelling at the injection site; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache), FATIGUE (tiredness), VACCINATION SITE BRUISING (bruising at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and FATIGUE (tiredness). On 21-Mar-2021, the patient experienced VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). On 21-Mar-2021, HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE BRUISING (bruising at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) had not resolved and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (small temperature increase), ASTHENIA (lost of any physical function, could not stand, no strength o his body) and DIZZINESS (light headed, dizzy) in a seventy-three-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (small temperature increase) and ASTHENIA (lost of any physical function, could not stand, no strength o his body). On 29-Mar-2021, the patient experienced DIZZINESS (light headed, dizzy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BODY TEMPERATURE INCREASED (small temperature increase), ASTHENIA (lost of any physical function, could not stand, no strength o his body) and DIZZINESS (light headed, dizzy) outcome was unknown.            His normal temperature is 97.5F but the following day he had 100.6-100.8 F after the vaccine, "small temperature increase"". 11.30 on Friday lost any physical function could not stand, laying on his back, no strength on his body. The following day he was better, could walk. Today feels dizzy and light headed.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness, Dry mouth, Dysgeusia
Clinical narrative: body and muscle was very tensed-made it hard to get up in the morning; metallic taste in her mouth; wicked chills; Light headedness; inside of her mouth became dry; dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth; inside of cheeks were peeling; tongue was tingling; lips got dry; body aches; sweating profusely; HR elevated to 100bpm; BP dropped to 90/77 mmHg,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling) and PARAESTHESIA ORAL (tongue was tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,) and CHILLS (wicked chills). On an unknown date, the patient experienced MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning) and DYSGEUSIA (metallic taste in her mouth). At the time of the report, DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,), MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning), DYSGEUSIA (metallic taste in her mouth) and CHILLS (wicked chills) outcome was unknown. Unknown          Concomitant information was not provided. Treatment information was not provided.  patient had partial pressure of oxygen ( blood O2) as 99% and treated with Tylenol and Ibuprofen.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Lip dry, Mucosal dryness, Muscle tightness
Clinical narrative: body and muscle was very tensed-made it hard to get up in the morning; metallic taste in her mouth; wicked chills; Light headedness; inside of her mouth became dry; dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth; inside of cheeks were peeling; tongue was tingling; lips got dry; body aches; sweating profusely; HR elevated to 100bpm; BP dropped to 90/77 mmHg,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling) and PARAESTHESIA ORAL (tongue was tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,) and CHILLS (wicked chills). On an unknown date, the patient experienced MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning) and DYSGEUSIA (metallic taste in her mouth). At the time of the report, DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,), MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning), DYSGEUSIA (metallic taste in her mouth) and CHILLS (wicked chills) outcome was unknown. Unknown          Concomitant information was not provided. Treatment information was not provided.  patient had partial pressure of oxygen ( blood O2) as 99% and treated with Tylenol and Ibuprofen.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal exfoliation, Pain, Paraesthesia oral
Clinical narrative: body and muscle was very tensed-made it hard to get up in the morning; metallic taste in her mouth; wicked chills; Light headedness; inside of her mouth became dry; dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth; inside of cheeks were peeling; tongue was tingling; lips got dry; body aches; sweating profusely; HR elevated to 100bpm; BP dropped to 90/77 mmHg,; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling) and PARAESTHESIA ORAL (tongue was tingling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,) and CHILLS (wicked chills). On an unknown date, the patient experienced MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning) and DYSGEUSIA (metallic taste in her mouth). At the time of the report, DIZZINESS (Light headedness), DRY MOUTH (inside of her mouth became dry), MUCOSAL DRYNESS (dehydrated/ she felt like all the water was being pulled from her body, metal fill-ins felt as if they were drying inside her mouth), ORAL MUCOSAL EXFOLIATION (inside of cheeks were peeling), PARAESTHESIA ORAL (tongue was tingling), LIP DRY (lips got dry), PAIN (body aches), HYPERHIDROSIS (sweating profusely), HEART RATE INCREASED (HR elevated to 100bpm), BLOOD PRESSURE DECREASED (BP dropped to 90/77 mmHg,), MUSCLE TIGHTNESS (body and muscle was very tensed-made it hard to get up in the morning), DYSGEUSIA (metallic taste in her mouth) and CHILLS (wicked chills) outcome was unknown. Unknown          Concomitant information was not provided. Treatment information was not provided.  patient had partial pressure of oxygen ( blood O2) as 99% and treated with Tylenol and Ibuprofen.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication
Clinical narrative: vaccine administered more than 6 hours; 2nd dose administered more than 12 hours after puncture; Adverse events related to the 2nd dose; 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 (vaccine administered more than 6 hours), EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered more than 6 hours), EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered more than 6 hours) had resolved and EXPIRED PRODUCT ADMINISTERED (2nd dose administered more than 12 hours after puncture) and VACCINATION COMPLICATION (Adverse events related to the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information not provided. Company comment: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031A21A)  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-APR-2021 .Events updated On 15-Jul-2021: follow up received and contain non significant information.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031A21A)  with no associated AEs.