chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: bruising at the injection site; red rash at the injection site; swelling at the injection site from elbow to the shoulder; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE BESILATE (NORVASC), ACETYLSALICYLIC ACID (ASPIRIN 81), CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, METOPROLOL TARTRATE (LOPRESSOR), ATORVASTATIN CALCIUM (LIPITOR), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Apr-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 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 16-Apr-2021, the patient experienced CONTUSION (bruising at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, CONTUSION (bruising at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (red rash at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site from elbow to the shoulder) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Eye swelling, Headache, Vision blurred
Clinical narrative: Eyes are swollen; Blurry vision; Cannot open eyes in the morning; Pain in the shoulders; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-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 EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches). At the time of the report, EYE SWELLING (Eyes are swollen), VISION BLURRED (Blurry vision), DISCOMFORT (Cannot open eyes in the morning), ARTHRALGIA (Pain in the shoulders) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079204 (E2B Linked Report).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: arm where I got the vaccine is swollen, red, and hot; arm where I got the vaccine is swollen,; size of a silver dollar; arm where I got the vaccine is swollen, red,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm where I got the vaccine is swollen, red, and hot), VACCINATION SITE SWELLING (arm where I got the vaccine is swollen,), VACCINATION SITE ERYTHEMA (arm where I got the vaccine is swollen, red,) and VACCINATION SITE URTICARIA (size of a silver dollar) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm where I got the vaccine is swollen, red,). On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm where I got the vaccine is swollen, red, and hot), VACCINATION SITE SWELLING (arm where I got the vaccine is swollen,) and VACCINATION SITE URTICARIA (size of a silver dollar). At the time of the report, VACCINATION SITE WARMTH (arm where I got the vaccine is swollen, red, and hot), VACCINATION SITE SWELLING (arm where I got the vaccine is swollen,) and VACCINATION SITE URTICARIA (size of a silver dollar) outcome was unknown and VACCINATION SITE ERYTHEMA (arm where I got the vaccine is swollen, red,) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Vaccination site pain
Clinical narrative: Dizziness; pain on R arm of injection; difficulty in breathing, can breath 70-80%; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%) in a 45-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 DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Muscle tightness, Swelling, Tenderness
Clinical narrative: Contracted COVID which lasted 2 weeks.; Redness; Swelling; Tenderness; Tightness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), MUSCLE TIGHTNESS (Tightness), COVID-19 (Contracted COVID which lasted 2 weeks.), ERYTHEMA (Redness) and SWELLING (Swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced TENDERNESS (Tenderness), MUSCLE TIGHTNESS (Tightness), ERYTHEMA (Redness) and SWELLING (Swelling). On 22-Mar-2021, the patient experienced COVID-19 (Contracted COVID which lasted 2 weeks.). At the time of the report, TENDERNESS (Tenderness), MUSCLE TIGHTNESS (Tightness), COVID-19 (Contracted COVID which lasted 2 weeks.), ERYTHEMA (Redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment details include Ibuprofen and Tylenol for fever and also icepacks.   This case was linked to MOD-2021-079276 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red face; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-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 16-Apr-2021, the patient experienced ERYTHEMA (Red face). At the time of the report, ERYTHEMA (Red face) outcome was unknown. Not Provided          No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over trunk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash over trunk). At the time of the report, RASH (Rash over trunk) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity, Swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No reported medical history. On Apr 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful). At the time of the report, limb injury (stubbed foot; swollen/painful), swelling (stubbed foot; swollen/painful) and pain in extremity (stubbed foot; swollen/painful) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment medication not reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: 4 knots on his right arm where he was injected,; keeps him up at night; arm is itchy; arm is red; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red). At the time of the report, SWELLING (4 knots on his right arm where he was injected,), INSOMNIA (keeps him up at night), VACCINATION SITE PRURITUS (arm is itchy) and VACCINATION SITE ERYTHEMA (arm is red) outcome was unknown.            TCR information provided that patient used alcohol to stop itchiness. Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.   This case was linked to INC.-MOD-2021-079227 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: TCR added on 20 May 2021 and does not get any additional contact information; Sender's Comments:  INC.-MOD-2021-079227: 1st dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chromaturia, Myalgia, Pyrexia, Thirst
Clinical narrative: temperature 100.4; very thirsty; excessive urination; went to the bathroom every 45 minutes to pee; urine turned dark in color \ urine looked like honey; muscle ache; This spontaneous case was reported by a patient and describes the occurrence of THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache). On 16-Apr-2021, the patient experienced PYREXIA (temperature 100.4). At the time of the report, THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey), MYALGIA (muscle ache) and PYREXIA (temperature 100.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 100.4 (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient stated that within 2 hours of stopping the water consumption, her urine turned dark in color. After she started consuming water again problem resolved itself. Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079248 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Added Adverse event Chromaturia; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079248:Case for first dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Urine output increased
Clinical narrative: temperature 100.4; very thirsty; excessive urination; went to the bathroom every 45 minutes to pee; urine turned dark in color \ urine looked like honey; muscle ache; This spontaneous case was reported by a patient and describes the occurrence of THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache). On 16-Apr-2021, the patient experienced PYREXIA (temperature 100.4). At the time of the report, THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey), MYALGIA (muscle ache) and PYREXIA (temperature 100.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 100.4 (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient stated that within 2 hours of stopping the water consumption, her urine turned dark in color. After she started consuming water again problem resolved itself. Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079248 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Added Adverse event Chromaturia; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079248:Case for first dose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis-like symptom, Dry skin, Pruritus
Clinical narrative: "dry scalp, white flakes fall on my blouse."; "Itchy scalp"; "dry areas on arms, skin on arm have looked and felt bad"; "For the last few days, I've bee having signs of cystitis."; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp"), DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad") and CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis.") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included ALPRAZOLAM (XANAX), SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THIAMINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis."). On an unknown date, the patient experienced DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp") and DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad"). At the time of the report, DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp"), DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad") and CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis.") had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable Patient medical history were not reported.  Concomitant medication also includes thyroid medication, vitamin B, calcium with vitamin D and  multivitamin. Treatment medicines were not reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: Patient felt like he had the COVID-19 virus all over again after the first dose like he did in; Patient had super severe headache immediately after the first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Migraine.    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 COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose). At the time of the report, COVID-19 (Patient felt like he had the COVID-19 virus all over again after the first dose like he did in) and HEADACHE (Patient had super severe headache immediately after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Dizziness
Clinical narrative: Confused; Dizzy; Short term memory loss; This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss) in a 46-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 (No reported medical history).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 16-Apr-2021, the patient experienced CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss). At the time of the report, CONFUSIONAL STATE (Confused), DIZZINESS (Dizzy) and AMNESIA (Short term memory loss) outcome was unknown. Not Provided      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.   Treatment medicines were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Nausea
Clinical narrative: Yellow Diarrhoea; felt sick, felt more sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Yellow Diarrhoea), ILLNESS (felt sick, felt more sick) and NAUSEA (nausea) in a female 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 07-Apr-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 10-Apr-2021, the patient experienced NAUSEA (nausea). On 14-Apr-2021, the patient experienced ILLNESS (felt sick, felt more sick). On 15-Apr-2021, the patient experienced DIARRHOEA (Yellow Diarrhoea). At the time of the report, DIARRHOEA (Yellow Diarrhoea) and ILLNESS (felt sick, felt more sick) outcome was unknown and NAUSEA (nausea) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment information were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: ash in left arm where they administered the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (ash in left arm where they administered the vaccine) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE RASH (ash in left arm where they administered the vaccine). At the time of the report, VACCINATION SITE RASH (ash in left arm where they administered the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No other relevant concomitant medication were reported. No treatment information were reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site warm; big red swatch 2 to 3 inches long from injection site down arm; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen). At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE ERYTHEMA (big red swatch 2 to 3 inches long from injection site down arm) and VACCINATION SITE SWELLING (injection site swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable No treatment information were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm Soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, 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 (Arm Soreness) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 and updated event outcome
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pain
Clinical narrative: Hard time breathing; Body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Hard time breathing), PAIN (Body ache) and CHILLS (chills) outcome was unknown. Not Provided          The patient got first dose 4 weeks back. He did not have symptoms after the first shot. Patient concomitant medication include diabetic medication Action taken with mRNA-1273 in response to the event was not applicable
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: arm is red and a little hot and itchy; arm is red and a little hot and itchy; arm is red and a little hot and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN B5 [PANTOTHENIC ACID] and VITAMIN B9 for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy). At the time of the report, VACCINATION SITE WARMTH (arm is red and a little hot and itchy), VACCINATION SITE PRURITUS (arm is red and a little hot and itchy) and VACCINATION SITE ERYTHEMA (arm is red and a little hot and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal rigidity, Headache, Post procedural discharge, Vomiting
Clinical narrative: Bad headache; Bad pain in the middle part of stomach/pain went to middle of back; Ostomy bag output was really watery; Stomach was as hard as rock; Threw up a couple of times; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Bad pain in the middle part of stomach/pain went to middle of back), POST PROCEDURAL DISCHARGE (Ostomy bag output was really watery), ABDOMINAL RIGIDITY (Stomach was as hard as rock), VOMITING (Threw up a couple of times) and HEADACHE (Bad headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Ostomy bag placement since an unknown date. Concomitant products included METFORMIN, LINAGLIPTIN (TRADJENTA), VALSARTAN, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), PROBIOTICS NOS, FAMOTIDINE (PEPCID [FAMOTIDINE]), CALCIUM, LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN (Bad pain in the middle part of stomach/pain went to middle of back), ABDOMINAL RIGIDITY (Stomach was as hard as rock) and VOMITING (Threw up a couple of times). 15-Apr-2021, the patient experienced POST PROCEDURAL DISCHARGE (Ostomy bag output was really watery). On 16-Apr-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 16-Apr-2021, ABDOMINAL PAIN (Bad pain in the middle part of stomach/pain went to middle of back), ABDOMINAL RIGIDITY (Stomach was as hard as rock) and VOMITING (Threw up a couple of times) had resolved. At the time of the report, POST PROCEDURAL DISCHARGE (Ostomy bag output was really watery) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional treatment details included that doctor advised to stay hydrated.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up information received on 12 June 2021 and updated event stop date and outcome On 16-Jun-2021: Follow-up information received on 16-JUNE-2021 contains no new informaton
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia
Clinical narrative: bad hangover headache; sleep for 4 hours; chills within 40 minutes of shot; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleep for 4 hours), CHILLS (chills within 40 minutes of shot), FATIGUE (fatigue) and HEADACHE (bad hangover headache) in a female 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. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), GABAPENTIN, VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INSOMNIA (sleep for 4 hours), CHILLS (chills within 40 minutes of shot) and FATIGUE (fatigue). On 19-Mar-2021, the patient experienced HEADACHE (bad hangover headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 19-Mar-2021, INSOMNIA (sleep for 4 hours), CHILLS (chills within 40 minutes of shot), FATIGUE (fatigue) and HEADACHE (bad hangover headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he had a lot of energy 2 days afterwards. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked toMOD-2021-079292 (E2B Linked Report).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: aches,pain; arm pain; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever) in a 66-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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever). At the time of the report, PAIN (aches,pain), PAIN IN EXTREMITY (arm pain) and PYREXIA (slight fever) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable No treatment information was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pain in extremity
Clinical narrative: Right arm was sore; Have stuffy Nose; Had Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore), NASAL CONGESTION (Have stuffy Nose), CHILLS (Had Chills) and HEADACHE (Headaches) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 037B21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore), NASAL CONGESTION (Have stuffy Nose), CHILLS (Had Chills) and HEADACHE (Headaches). On 14-Mar-2021, PAIN IN EXTREMITY (Right arm was sore) and HEADACHE (Headaches) had resolved. At the time of the report, NASAL CONGESTION (Have stuffy Nose) and CHILLS (Had Chills) had not resolved.            .Patient took Tylenol for headache Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079284:Case for dose 2
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness in injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE for COPD, DILTIAZEM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TAMSULOSIN, IBUPROFEN, FINASTERIDE, MONTELUKAST and LORATADINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness in injection site) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No treatment was taken by the patient.   This case was linked to US-MODERNATX, INC.-MOD-2021-079246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079246:Wife case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: terrible stiff neck; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (terrible stiff neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN B COMPLEX (B COMPLEX (B50)) and VITAMIN D NOS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (terrible stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (terrible stiff neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included 3 tablets ibuprofen and 2 tablets of acetaminophen.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Lymphadenopathy, Neck pain, Pruritus
Clinical narrative: injection site was swollen/itching/red down to underside of arm; itching; bruising at site of injection (which patient states was administered very high up this time); severe neck pain on the left side; swollen glands; dizziness (preventing her from getting up); waking up sweating (just like when she had COVID; very high temperature of 103.5 F; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands) and DIZZINESS (dizziness (preventing her from getting up)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 22-Mar-2021.   On 12-Apr-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 12-Apr-2021, the patient experienced PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and PYREXIA (very high temperature of 103.5 F). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm). At the time of the report, PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm) outcome was unknown, NECK PAIN (severe neck pain on the left side) had resolved and PYREXIA (very high temperature of 103.5 F) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 103.5 (High) Fever. On 16-Apr-2021, Pyrexia: 100.1 (High) fever.         Patient took Ibuprofen and Tylenol for fever and also used ice packs. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-079254 (E2B Linked Report). This case was linked to MOD-2021-079254 (Patient Link).; Sender's Comments:  MOD-2021-079254:Dose 1
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: injection site was swollen/itching/red down to underside of arm; itching; bruising at site of injection (which patient states was administered very high up this time); severe neck pain on the left side; swollen glands; dizziness (preventing her from getting up); waking up sweating (just like when she had COVID; very high temperature of 103.5 F; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands) and DIZZINESS (dizziness (preventing her from getting up)) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 22-Mar-2021.   On 12-Apr-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 12-Apr-2021, the patient experienced PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), NECK PAIN (severe neck pain on the left side), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and PYREXIA (very high temperature of 103.5 F). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm). At the time of the report, PRURITUS (itching), VACCINATION SITE BRUISING (bruising at site of injection (which patient states was administered very high up this time)), LYMPHADENOPATHY (swollen glands), DIZZINESS (dizziness (preventing her from getting up)), HYPERHIDROSIS (waking up sweating (just like when she had COVID) and VACCINATION SITE SWELLING (injection site was swollen/itching/red down to underside of arm) outcome was unknown, NECK PAIN (severe neck pain on the left side) had resolved and PYREXIA (very high temperature of 103.5 F) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 103.5 (High) Fever. On 16-Apr-2021, Pyrexia: 100.1 (High) fever.         Patient took Ibuprofen and Tylenol for fever and also used ice packs. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-079254 (E2B Linked Report). This case was linked to MOD-2021-079254 (Patient Link).; Sender's Comments:  MOD-2021-079254:Dose 1
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pain
Clinical narrative: could not walk - still cannot walk; a lot of pain; is in agony; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony) in a 65-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.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony). At the time of the report, GAIT INABILITY (could not walk - still cannot walk), PAIN (a lot of pain) and PAIN (is in agony) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication was reported. Treatment medication included Muscle relaxer and Pain Pills.   This case was linked to US-MODERNATX, INC.-MOD-2021-079434 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079434:Sister's case
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: While administering needle got disconnected; While administering needle got disconnected; 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 DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected). At the time of the report, DEVICE CONNECTION ISSUE (While administering needle got disconnected) and UNDERDOSE (While administering needle got disconnected) 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.