chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Hypersensitivity, Vaccination site pruritus
Clinical narrative: tired all week; covid arm; big red spot on the arm; itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired all week), HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-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 27-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site). On an unknown date, the patient experienced FATIGUE (tired all week). At the time of the report, FATIGUE (tired all week), HYPERSENSITIVITY (covid arm), ERYTHEMA (big red spot on the arm) and VACCINATION SITE PRURITUS (itchiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Illness, Malaise
Clinical narrative: Headache; Body ache; Sore throat; Nausea; Coughing; Wheezing; Extremely ill; very tired and Completely wiped out; Scary sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea) and COUGH (Coughing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (patient had 2 back surgeries). Concomitant products included OXYCODONE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LEVOTHYROXINE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick). At the time of the report, HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick) 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.   Treatment medications were not provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Wheezing
Clinical narrative: Headache; Body ache; Sore throat; Nausea; Coughing; Wheezing; Extremely ill; very tired and Completely wiped out; Scary sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea) and COUGH (Coughing) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (patient had 2 back surgeries). Concomitant products included OXYCODONE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LEVOTHYROXINE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick). At the time of the report, HEADACHE (Headache), PAIN (Body ache), OROPHARYNGEAL PAIN (Sore throat), NAUSEA (Nausea), COUGH (Coughing), WHEEZING (Wheezing), MALAISE (Extremely ill), FATIGUE (very tired and Completely wiped out) and ILLNESS (Scary sick) 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.   Treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: concerned may have not received a full dose; syringe connection issues; A spontaneous report  was received from a consumer, who was also a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and during administration, some drops leaked out of the syringe (device connection issue) and she was concerned that she may have not received a full dose (underdose).  The patient's medical history was not reported. No concomitant product use was reported.  On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, during administration, the patient noticed some drops leaked out of the syringe and was concerned that she might have not received a full dose and was asking what to do.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events was recovered on 26 Feb 2021.; Reporter's Comments: This report refers to a case of a female patient of unknown age who experienced non-serious unexpected events of some drops leaked out of the syringe ( syringe issue) and  she was concerned that she may have not received a full dose ( Incomplete dose administered) for  mRNA-1273 (Lot number: 012A21A) . There were no reported AEs associated with this case of syringe issue and incomplete dose administered
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Pruritus, Swelling
Clinical narrative: Warm; swollen from shoulder to elbow; arm got sore again; got severe itching; I had sore arm for day or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I had sore arm for day or so), PAIN IN EXTREMITY (arm got sore again), PRURITUS (got severe itching), INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN, MIRABEGRON (MYRBETRIQ), CHLORDIAZEPOXIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]) and BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (I had sore arm for day or so). On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got sore again) and PRURITUS (got severe itching). On 28-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (I had sore arm for day or so), PAIN IN EXTREMITY (arm got sore again), PRURITUS (got severe itching), INJECTION SITE WARMTH (Warm) and SWELLING (swollen from shoulder to elbow) outcome was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Nausea
Clinical narrative: shortness of breath; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DYSPNOEA (shortness of breath), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up was received on 02-JUN-2021, and contains updated contact information.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a bad rash that started 2 weeks after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a bad rash that started 2 weeks after receiving the vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for an unknown indication.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced RASH (a bad rash that started 2 weeks after receiving the vaccine). At the time of the report, RASH (a bad rash that started 2 weeks after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation
Clinical narrative: itching on her back; burning on her back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on her back) and SKIN BURNING SENSATION (burning on her back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itching on her back) and SKIN BURNING SENSATION (burning on her back). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itching on her back) and SKIN BURNING SENSATION (burning on her back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 and the event outcome was updated from unknown to recovered
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: sore arm; temperature was near 100 degrees F; chills at night, was very cold, woke up freezing; chills at night, was very cold, woke up freezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING COLD (chills at night, was very cold, woke up freezing), PYREXIA (temperature was near 100 degrees F) and CHILLS (chills at night, was very cold, woke up freezing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 041L20A) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and ROSUVASTATIN (STATINOR [ROSUVASTATIN]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 FEELING COLD (chills at night, was very cold, woke up freezing) and CHILLS (chills at night, was very cold, woke up freezing). On 26-Feb-2021, the patient experienced PYREXIA (temperature was near 100 degrees F). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING COLD (chills at night, was very cold, woke up freezing), PYREXIA (temperature was near 100 degrees F) and CHILLS (chills at night, was very cold, woke up freezing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MOD-2021-028418, MOD-2021-028418 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pruritus, Rash pustular, Skin discolouration
Clinical narrative: Yesterday it started itching; injection site is like the size of an egg; very hot; raised; painful; very noticeable.; has 4 little white rings with a dot on it that is about the size of a pinky fingertip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised) and PAIN (painful) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip). At the time of the report, PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Skin warm
Clinical narrative: Yesterday it started itching; injection site is like the size of an egg; very hot; raised; painful; very noticeable.; has 4 little white rings with a dot on it that is about the size of a pinky fingertip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised) and PAIN (painful) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip). At the time of the report, PRURITUS (Yesterday it started itching), INJECTION SITE SWELLING (injection site is like the size of an egg), SKIN WARM (very hot), SKIN REACTION (raised), PAIN (painful), RASH PUSTULAR (very noticeable.) and SKIN DISCOLOURATION (has 4 little white rings with a dot on it that is about the size of a pinky fingertip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness at the vaccine site; Redness at the vaccine site/itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the vaccine site) in a 79-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.). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC), VALSARTAN, FISH OIL, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 18-Feb-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 VACCINATION SITE ERYTHEMA (Redness at the vaccine site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the vaccine site) 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.   Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure decreased, Chest pain, Hypertension, Pain
Clinical narrative: Chest pain; High blood pressure reaction; Some itching on her arm and aching.; Some itching on her arm and aching.; Some itching on her arm and aching.; Terrible shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.) in a 75-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.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), ISOSORBIDE MONONITRATE (ISOSORBID MONONITRATE), VITAMIN B12 NOS, MULTIVITAMINS [VITAMINS NOS], CALCIUM CITRATE and PARACETAMOL (TYLENOL) for an unknown indication, PARACETAMOL (TYLENOL).   On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (Terrible shoulder pain). On 19-Feb-2021, the patient experienced HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.). On 24-Feb-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.), PAIN (Some itching on her arm and aching.) and ARTHRALGIA (Terrible shoulder pain) outcome was unknown and HYPERTENSION (High blood pressure reaction) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of the event hypertension(from unknown to resolved)was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Chest pain; High blood pressure reaction; Some itching on her arm and aching.; Some itching on her arm and aching.; Some itching on her arm and aching.; Terrible shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.) in a 75-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.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), ISOSORBIDE MONONITRATE (ISOSORBID MONONITRATE), VITAMIN B12 NOS, MULTIVITAMINS [VITAMINS NOS], CALCIUM CITRATE and PARACETAMOL (TYLENOL) for an unknown indication, PARACETAMOL (TYLENOL).   On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (Terrible shoulder pain). On 19-Feb-2021, the patient experienced HYPERTENSION (High blood pressure reaction), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.) and PAIN (Some itching on her arm and aching.). On 24-Feb-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain), BLOOD PRESSURE DECREASED (Some itching on her arm and aching.), PRURITUS (Some itching on her arm and aching.), PAIN (Some itching on her arm and aching.) and ARTHRALGIA (Terrible shoulder pain) outcome was unknown and HYPERTENSION (High blood pressure reaction) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of the event hypertension(from unknown to resolved)was updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site induration, Vaccination site warmth
Clinical narrative: itchy arm -26 Feb 2021; swollen arm- -26 Feb 2021; hard at injection site -26 Feb 2021; warm at injection site -26 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021). At the time of the report, PRURITUS (itchy arm -26 Feb 2021), PERIPHERAL SWELLING (swollen arm- -26 Feb 2021), VACCINATION SITE INDURATION (hard at injection site -26 Feb 2021) and VACCINATION SITE WARMTH (warm at injection site -26 Feb 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dosing window; A spontaneous report was received from a consumer concerning a 70-year-old, female patient, who received only the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and missed the second dose becoming out of window by the time of the report.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A ) intramuscularly for prophylaxis of COVID-19 infection.   By 26-Feb-2021, the patient missed dosing window. Her daughter called to ask if the patient has to start over with the vaccination schedule.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was resolved; Reporter's Comments: This report refers to a case of missed second dose of mRNA-1273, lot not applicable, with no associated AEs.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash was red, itchy and very painful. It was triangular shaped; red, itchy and very painful rash; red, itchy and very painful rash; Small rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Small rash at the injection site), VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (Small rash at the injection site). On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash). On 28-Feb-2021, VACCINATION SITE RASH (Small rash at the injection site) had resolved. On 01-Mar-2021, VACCINATION SITE ERYTHEMA (red, itchy and very painful rash), VACCINATION SITE PRURITUS (Rash was red, itchy and very painful. It was triangular shaped) and VACCINATION SITE PAIN (red, itchy and very painful rash) had resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes on her torso; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes on her torso) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced RASH (rashes on her torso). At the time of the report, RASH (rashes on her torso) outcome was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: arm soreness; chills; low grade fever for more than 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), CHILLS (chills) and PYREXIA (low grade fever for more than 48 hours) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included ALFUZOSIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness), CHILLS (chills) and PYREXIA (low grade fever for more than 48 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm soreness), CHILLS (chills) and PYREXIA (low grade fever for more than 48 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Alfuzosin for  unspecified prostate disease.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: big bump below her arm; itchy; rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (big bump below her arm), PRURITUS (itchy) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Receive 0.3ml instead of 0.5ml first dose; A spontaneous report  was received from a friend of the patient concerning an elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and receive 0.3 ml instead of 0.5 ml first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided). On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.  The friend of the patient reported that the patient was frantic and worried about first dose of Moderna vaccine she got. She stated that this elderly lady received 0.3 ml of the first dose and 0.5 ml second dose. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273, therefore action taken with the drug in response to the events was not applicable.  The event received 0.3 ml instead of 0.5 ml first dose, was considered resolved.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental underdose without any associated adverse events.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Headache, Peripheral swelling
Clinical narrative: swollen finger from left and right hand; hot to touch at site of injection; elevated temperature on the arm; redness; Fatigue; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prediabetes and Anemic. Concomitant products included IRON for Anemic, METFORMIN for Prediabetes.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache). On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen finger from left and right hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra Strength: 2 tablets and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 tablet. At the time of the report, VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: elevated (High) elevated temperature on the arm.         Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: swollen finger from left and right hand; hot to touch at site of injection; elevated temperature on the arm; redness; Fatigue; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Prediabetes and Anemic. Concomitant products included IRON for Anemic, METFORMIN for Prediabetes.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache). On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen finger from left and right hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Extra Strength: 2 tablets and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 tablet. At the time of the report, VACCINATION SITE WARMTH (hot to touch at site of injection), FEELING HOT (elevated temperature on the arm), PERIPHERAL SWELLING (swollen finger from left and right hand), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: elevated (High) elevated temperature on the arm.         Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: Dizzy; Arm is killing; very weak; Couldn't hardly eat; injected thru the band aid in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) and CHILLS (Chills). On 26-Feb-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) had resolved. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Dizzy; Arm is killing; very weak; Couldn't hardly eat; injected thru the band aid in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) and CHILLS (Chills). On 26-Feb-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (injected thru the band aid in arm) had resolved. At the time of the report, DIZZINESS (Dizzy), PAIN IN EXTREMITY (Arm is killing), ASTHENIA (very weak), DECREASED APPETITE (Couldn't hardly eat) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03L20A and 030A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm). On 06-Feb-2021, PAIN IN EXTREMITY (Really sore arm) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information in response to event was not provided.   This case was linked to MOD-2021-036307 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional information: Contact info updated; Sender's Comments:  MOD-2021-036307:Dose 2 case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dizziness, Dyspnoea, Fatigue, Malaise
Clinical narrative: Heart Racing; out of breath; shaky; dizzy; exhausted always; just don't feel good; voice keeps going out; A spontaneous report was received from a type concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart racing(palpation), shaky(tremors), dizzy(dizziness), exhausted always(fatigue), out of breath (dyspnea), just don't feel good (malaise), voice keeps going out (aphonia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out.  Treatment details included Beta blocker.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: Heart Racing; out of breath; shaky; dizzy; exhausted always; just don't feel good; voice keeps going out; A spontaneous report was received from a type concerning a 66-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events heart racing(palpation), shaky(tremors), dizzy(dizziness), exhausted always(fatigue), out of breath (dyspnea), just don't feel good (malaise), voice keeps going out (aphonia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out.  Treatment details included Beta blocker.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, heart racing, shaky, dizzy, exhausted always, out of breath, just don't feel good, bad reaction, voice keeps going out was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neuralgia
Clinical narrative: Her shingles virus "woke up", she had the same nerve pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches) 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 Shingles.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches). At the time of the report, NEURALGIA (Her shingles virus "woke up", she had the same nerve pain) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received and outcome of the events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: extremely itchy; huge rash around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site) 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 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site). At the time of the report, INJECTION SITE PRURITUS (extremely itchy) and INJECTION SITE RASH (huge rash around the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up was received and consent was declined.