chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Enlarged uvula, Pharyngeal erythema
Clinical narrative: uvula in my throat swelled / my uvula was larger than normal; uvula in my throat turned red /  my throat at home and saw it was red.; Allergy to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal), PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to sting (entire body covered in hives, severe itching, very low blood pressure, almost fainted, treated at ER) since 30-Jul-2015, Allergy to antibiotic (Dicloxacillan causes difficulty swallowing) since 24-Oct-1996, Allergy to antibiotic (Ciprofloxacin causes thigh muscle pain) since 2002, Drug allergy (Rosuvastatin causes neck pain, itchy rash on leg) since 15-Apr-2021 and Hypertension since 05-Jan-1999. Concomitant products included BENAZEPRIL HCL from 15-Jan-2016 to an unknown date and HYDROCHLOROTHIAZIDE from 15-Jan-2016 to an unknown date for Hypertension, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) from 01-Jun-2010 to an unknown date for Retinal drusen, PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal), PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine). On 04-Feb-2021, ENLARGED UVULA (uvula in my throat swelled / my uvula was larger than normal) had resolved. On 05-Feb-2021, PHARYNGEAL ERYTHEMA (uvula in my throat turned red /  my throat at home and saw it was red.) and ALLERGY TO VACCINE (Allergy to vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter   This case was linked to MOD-2021-248974 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26APR2021, updated AE information On 06-Jul-2021: Significant follow-up received on 06JUL2021, updated reporter details, patient demographics, past medical history, patient received 2nd dose on 30APR2021; Lot no 026A21A, Concomitant medications, events end date added.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Nausea, Tremor
Clinical narrative: experiencing severe pain in lower abdomen, in the pelvis area; Shaking; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 03AK20A) for COVID-19 vaccination.     The patient's past medical history included Lower limb fracture (Patient broke her leg years ago.).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue/Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (fatigue/Tiredness) 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 28-Jan-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) at an unspecified dose. On 01-Feb-2021, the patient experienced FATIGUE (fatigue/Tiredness). At the time of the report, FATIGUE (fatigue/Tiredness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to Touch Sensation - Near Injection Site; Pain - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; Itchy Sensation - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site). At the time of the report, VACCINATION SITE WARMTH (Warm to Touch Sensation - Near Injection Site), VACCINATION SITE PAIN (Pain - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) 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.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: itching; big red oval; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval) 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. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Feb-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red oval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: light fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (light fever) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (light fever). At the time of the report, PYREXIA (light fever) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PYREXIA (A little bit of fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced PYREXIA (A little bit of fever) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PYREXIA (A little bit of fever) and CHILLS (Chills) outcome was unknown. No Concomitant medications were reported. The patient took Tylenol as treatment medication. This case was linked to MOD-2021-038916 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: body aches; eyes burned; dizzy; fatigued; sore in her arm (injection site); This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizzy), FATIGUE (fatigued), VACCINATION SITE PAIN (sore in her arm (injection site)), MYALGIA (body aches) and EYE IRRITATION (eyes burned) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (dizzy), FATIGUE (fatigued), VACCINATION SITE PAIN (sore in her arm (injection site)) and EYE IRRITATION (eyes burned). On 07-Feb-2021, the patient experienced MYALGIA (body aches). At the time of the report, DIZZINESS (dizzy), FATIGUE (fatigued), VACCINATION SITE PAIN (sore in her arm (injection site)), MYALGIA (body aches) and EYE IRRITATION (eyes burned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication nor treatment provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: tenderness and soreness at site of injection; itching site of injection; soreness at site of injection; site of injection feels warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness and soreness at site of injection), VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy since an unknown date. Concurrent medical conditions included Hypertension.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (tenderness and soreness at site of injection). In February 2021, the patient experienced VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Tenderness, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (tenderness and soreness at site of injection), VACCINATION SITE PRURITUS (itching site of injection), VACCINATION SITE PAIN (soreness at site of injection) and VACCINATION SITE WARMTH (site of injection feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Vertigo
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VERTIGO (Vertigo) and NASOPHARYNGITIS (Cold) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis. Concomitant products included RISEDRONATE SODIUM (ACTONEL) from 02-Feb-2021 to an unknown date for Osteoporosis. On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VERTIGO (Vertigo) and NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm), VERTIGO (Vertigo) and NASOPHARYNGITIS (Cold) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication nor treatment information provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site reaction
Clinical narrative: itching; Red; Ugly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly) in an 84-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 medical history provided).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching and Erythema, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), ERYTHEMA (Red) and VACCINATION SITE REACTION (Ugly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided Patient was treated symptoms with using Ice   This case was linked to MOD-2021-018461 (E2B Linked Report). This case was linked to MOD-2021-018437 (Patient Link).; Sender's Comments:  MOD-2021-018461:wife's case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Extremely thirsty; Arm swollen; Headache; Nose, eyebrow and cheek reddish in color; fever; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever) in a 71-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 medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever). At the time of the report, DEHYDRATION (Extremely thirsty), PERIPHERAL SWELLING (Arm swollen), HEADACHE (Headache), ERYTHEMA (Nose, eyebrow and cheek reddish in color) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment nor concomitant medication provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache and Chills, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: NNI; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product availability issue
Clinical narrative: There were no vaccines left at the facility; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well) and PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (Did not feel well). On 17-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility). On 22-Jan-2021, MALAISE (Did not feel well) had not resolved. On 17-Feb-2021, PRODUCT AVAILABILITY ISSUE (There were no vaccines left at the facility) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to event was not provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test, Sneezing
Clinical narrative: Positive covid test; Slight fever; Sneezing; Cough; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), COUGH (Cough), COVID-19 (Positive covid test) and PYREXIA (Slight fever) in a 66-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 (No reported medical history).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced SNEEZING (Sneezing), COUGH (Cough) and PYREXIA (Slight fever). On 27-Jan-2021, the patient experienced COVID-19 (Positive covid test). At the time of the report, SNEEZING (Sneezing), COUGH (Cough), COVID-19 (Positive covid test) and PYREXIA (Slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication nor treatment information provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: swollen arm; hard and raised welt; red arm; hot arm; sore to the touch arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included Omeprazole                                                     as needed, UBIDECARENONE (COQ), CALCIUM, SELENIUM, NIACINAMIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DOCUSATE, Loratidine, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MAGNESIUM, MELATONIN, PSYLLIUM HUSK [PLANTAGO OVATA HUSK], MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and BIOFLAVONOIDS NOS, RESVERATROL, VITIS VINIFERA SEED (GRAPESEED EXTRACT [BIOFLAVONOIDS NOS;RESVERATROL;VITIS VINIFERA SEED]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache). On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm). On 10-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. Patient regularly takes showers.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: swollen arm; hard and raised welt; red arm; hot arm; sore to the touch arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included Omeprazole                                                     as needed, UBIDECARENONE (COQ), CALCIUM, SELENIUM, NIACINAMIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), DOCUSATE, Loratidine, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), MAGNESIUM, MELATONIN, PSYLLIUM HUSK [PLANTAGO OVATA HUSK], MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) and BIOFLAVONOIDS NOS, RESVERATROL, VITIS VINIFERA SEED (GRAPESEED EXTRACT [BIOFLAVONOIDS NOS;RESVERATROL;VITIS VINIFERA SEED]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache). On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm). On 10-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE INDURATION (hard and raised welt), ERYTHEMA (red arm), FEELING HOT (hot arm) and PAIN IN EXTREMITY (sore to the touch arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. Patient regularly takes showers.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Flushing, Paraesthesia
Clinical narrative: 5 or 10 minutes after the injection, I got a flushing sensation from the base of the neck up to my jaw; it felt like blood pressure was going up or something; tingliness in the forearm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (5 or 10 minutes after the injection, I got a flushing sensation from the base of the neck up to my jaw), BLOOD PRESSURE INCREASED (it felt like blood pressure was going up or something) and PARAESTHESIA (tingliness in the forearm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery since an unknown date.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FLUSHING (5 or 10 minutes after the injection, I got a flushing sensation from the base of the neck up to my jaw), BLOOD PRESSURE INCREASED (it felt like blood pressure was going up or something) and PARAESTHESIA (tingliness in the forearm). On 15-Feb-2021, FLUSHING (5 or 10 minutes after the injection, I got a flushing sensation from the base of the neck up to my jaw), BLOOD PRESSURE INCREASED (it felt like blood pressure was going up or something) and PARAESTHESIA (tingliness in the forearm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; Rash - Near Injection Site; Arm Soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). On 12-Feb-2021, PAIN IN EXTREMITY (Arm Soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included cefalexin, advised by HCP to try and help alleviate the symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Hot to Touch Sensation - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Swelling - Near Injection Site; Rash - Near Injection Site; Arm Soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness), VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). On 12-Feb-2021, PAIN IN EXTREMITY (Arm Soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to Touch Sensation - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included cefalexin, advised by HCP to try and help alleviate the symptoms.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Soreness at the injection site that run up to the neck; Little itching at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included heart pace maker. Concomitant products included IRON 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site). On 18-Feb-2021, INJECTION SITE PAIN (Soreness at the injection site that run up to the neck) and INJECTION SITE PRURITUS (Little itching at the injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Allergy medication, Medication for asthma & Medication that helps her to breathe are taken as concomitant medicines.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: arm was itching; arm was red; arm was ugly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly) 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 (No medical history reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (arm was itching), VACCINATION SITE ERYTHEMA (arm was red) and VACCINATION SITE REACTION (arm was ugly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Other treatment details included applying ice.    This case was linked to MOD-2021-018425 (Patient Link).   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossitis, Headache, Nausea, Throat irritation
Clinical narrative: Fatigue; Tingly tongue; throat felt itchy; Headache; Nauseous; This spontaneous case was reported by a nurse and describes the occurrence of GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache) and NAUSEA (Nauseous). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GLOSSITIS (Tingly tongue), THROAT IRRITATION (throat felt itchy), HEADACHE (Headache), NAUSEA (Nauseous) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body ache) and PYREXIA (fever). At the time of the report, PAIN (Body ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 104f (Inconclusive) 104F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Clinomania, Headache, Pain in extremity
Clinical narrative: arm sore; difficulty in going out of bed; fever; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm sore), CLINOMANIA (difficulty in going out of bed), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L02A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, ROSUVASTATIN, AMLODIPINE, CALCIUM, VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 31-Jan-2021, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and CLINOMANIA (difficulty in going out of bed). At the time of the report, PAIN IN EXTREMITY (arm sore), CLINOMANIA (difficulty in going out of bed), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2020, White blood cell count (3.8-10.8): Low. In June 2020, White blood cell count (3.8-10.8): Low. On 14-Jan-2021, White blood cell count (3.8-10.8): 3.7 Low. On an unknown date, Body temperature: (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216190 (Patient Link).; Reporter's Comments: Her treating physician referred that her WBC low is normal for her.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, White blood cell count
Clinical narrative: arm sore; difficulty in going out of bed; fever; headache; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm sore), CLINOMANIA (difficulty in going out of bed), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L02A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE, ROSUVASTATIN, AMLODIPINE, CALCIUM, VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 31-Jan-2021, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and CLINOMANIA (difficulty in going out of bed). At the time of the report, PAIN IN EXTREMITY (arm sore), CLINOMANIA (difficulty in going out of bed), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2020, White blood cell count (3.8-10.8): Low. In June 2020, White blood cell count (3.8-10.8): Low. On 14-Jan-2021, White blood cell count (3.8-10.8): 3.7 Low. On an unknown date, Body temperature: (High) 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216190 (Patient Link).; Reporter's Comments: Her treating physician referred that her WBC low is normal for her.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site). At the time of the report, VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site) 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 20-Apr-2021: Non significant follow up added. Email address updated.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Epistaxis
Clinical narrative: nose bleed, never had one in her life before; her symptoms have gotten worse; Hand feels that there is Fire in her hands; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed, never had one in her life before), CONDITION AGGRAVATED (her symptoms have gotten worse) and BURNING SENSATION (Hand feels that there is Fire in her hands) 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 EPISTAXIS (nose bleed, never had one in her life before), CONDITION AGGRAVATED (her symptoms have gotten worse) and BURNING SENSATION (Hand feels that there is Fire in her hands). At the time of the report, EPISTAXIS (nose bleed, never had one in her life before) outcome was unknown and CONDITION AGGRAVATED (her symptoms have gotten worse) and BURNING SENSATION (Hand feels that there is Fire in her hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received which contains new events of condition aggravated and burning sensation was added
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort
Clinical narrative: bad headache; arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort). At the time of the report, HEADACHE (bad headache) and LIMB DISCOMFORT (arm discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment and concomitant medication was reported. Consent given for Safety Division to follow up with her if needed.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching; huge red thing; A spontaneous report was received from a consumer concerning a male  patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching/pruritus, huge red thing/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the events, itching, huge red thing.  Treatment information include ice and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, itching, huge red thing was unknown.