chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: stiffness; barely able to move; muscle aches; fever of 100.6; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.6 (Inconclusive) 100.6.         No treatment information was provided.  No concomitant medications were provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia, Sensitive skin
Clinical narrative: Arm Sensitivity; Body Aches; Headache; Fever - Temperature of 99.6F; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 12-Mar-2021, SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: a little itchy; Read rash that starts at the injection site and goes down 5inches and is about 3 inches wide/ not super red and angry/trails off into down 5 inches and off to the side like behind the arm; red on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a little itchy), VACCINATION SITE RASH (Read rash that starts at the injection site and goes down 5inches and is about 3 inches wide/ not super red and angry/trails off into down 5 inches and off to the side like behind the arm) and VACCINATION SITE ERYTHEMA (red on her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001321A (unclear) and 0316201A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021 at 10:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE RASH (Read rash that starts at the injection site and goes down 5inches and is about 3 inches wide/ not super red and angry/trails off into down 5 inches and off to the side like behind the arm) and VACCINATION SITE ERYTHEMA (red on her arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (a little itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) on 12-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (a little itchy), VACCINATION SITE RASH (Read rash that starts at the injection site and goes down 5inches and is about 3 inches wide/ not super red and angry/trails off into down 5 inches and off to the side like behind the arm) and VACCINATION SITE ERYTHEMA (red on her arm) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient states there was read rash that starts at the injection site and goes down 5inches and is about 3 inches wide; not super red and angry; trails off into down 5 inches and off to the side like behind the arm. Caller indicates it is a little itchy but not terrible.   This case was linked to MOD-2021-044640 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore Arm; Really Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FATIGUE (Really Tired) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Hemorrhoids. Concurrent medical conditions included Diabetes and Blood pressure high.    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 PAIN IN EXTREMITY (Sore Arm), FATIGUE (Really Tired) and HEADACHE (Headache). On 28-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, FATIGUE (Really Tired) had not resolved and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose (95-130 mg/dl): 165 mg/dl (High) Increased  165 and 185mg/dl for 2 days..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid pain
Clinical narrative: really bad pain in my thyroid gland; This spontaneous case was reported by a consumer and describes the occurrence of THYROID PAIN (really bad pain in my thyroid gland) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (thyroid problems).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced THYROID PAIN (really bad pain in my thyroid gland). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, THYROID PAIN (really bad pain in my thyroid gland) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: No medical history was provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), FATIGUE (feels fatigued) and CHILLS (chills). On 07-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 15-Mar-2021, the patient experienced HEADACHE (On and off headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (On and off headache) and FATIGUE (feels fatigued) had not resolved and PYREXIA (fever), CHILLS (chills), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: No medical history was provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), FATIGUE (feels fatigued) and CHILLS (chills). On 07-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 15-Mar-2021, the patient experienced HEADACHE (On and off headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (On and off headache) and FATIGUE (feels fatigued) had not resolved and PYREXIA (fever), CHILLS (chills), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: a little lump under her armpit on the side of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (a little lump under her armpit on the side of the injection) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced AXILLARY MASS (a little lump under her armpit on the side of the injection). At the time of the report, AXILLARY MASS (a little lump under her armpit on the side of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received dose; A spontaneous report was received from a nurse concerning a 17-year-old patient of unspecified gender who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, it was reported that vaccination site inadvertently administered COVID-19 vaccine to a 17 year old..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, 17 year old received dose was considered as resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar elevated for over a week; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included INSULIN, PREGABALIN (LYRICA), ROPINIROLE HYDROCHLORIDE (REQUIP) and VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar elevated for over a week) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood glucose: unknown (High) Blood sugar elevated for over a week.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058631 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: extreme pain 8 out of 10; deep breath it hurts even more; sore for 3 weeks, lingering; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue) in a 65-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 was provided by the reporter. .    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (extreme pain 8 out of 10), PAIN (deep breath it hurts even more), VACCINATION SITE PAIN (sore for 3 weeks, lingering) and FATIGUE (fatigue) outcome was unknown.            Treatment medications of the patient were not provided. No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard and everything; Swelled up; Turned red; Her arm was a little bit sore to begin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard and everything), VACCINATION SITE SWELLING (Swelled up), VACCINATION SITE ERYTHEMA (Turned red) and VACCINATION SITE PAIN (Her arm was a little bit sore to begin) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her arm was a little bit sore to begin). On 14-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Hard and everything), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE ERYTHEMA (Turned red). At the time of the report, VACCINATION SITE INDURATION (Hard and everything), VACCINATION SITE SWELLING (Swelled up), VACCINATION SITE ERYTHEMA (Turned red) and VACCINATION SITE PAIN (Her arm was a little bit sore to begin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: slept for three days; sweat; dizziness; severe body ache; headache; chills; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013HNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Myalgia
Clinical narrative: slept for three days; sweat; dizziness; severe body ache; headache; chills; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013HNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (slept for three days), HYPERHIDROSIS (sweat), DIZZINESS (dizziness), MYALGIA (severe body ache), HEADACHE (headache), CHILLS (chills) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: itchiness on and off in the arm/itchiness in the legs; terrible pain in the arm; intense pain; Foot very swollen and the other one less swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen) had resolved.            Concomitant medications include high blood pressure medications, cholesterol  medication, diabetes medication.  It was reported that the doctor changed some of the medication the patient had been on and she started to improve.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up  information received on 25-May-2021 does not contain any new information. On 17-Jul-2021: Follow-up received on 19-JUL-2021 and event outcome was updated from unknown to recovered/resolved
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Swelling
Clinical narrative: Burning sensation from rash; Bumps where rash has occured; Reddish rash from toes to torso; Rash from toes to legs; Itchy from toes to legs; sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and RASH (Rash from toes to legs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 ATORVASTATIN, HYDROCHLOROTHIAZIDE, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 12-Mar-2021, the patient experienced PRURITUS (Itchy from toes to legs) and RASH (Rash from toes to legs). On 13-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured) and ERYTHEMA (Reddish rash from toes to torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch and Rash, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and RASH (Rash from toes to legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event reoccurred after being resolved when treated with Benadryl.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Burning sensation from rash; Bumps where rash has occured; Reddish rash from toes to torso; Rash from toes to legs; Itchy from toes to legs; sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and RASH (Rash from toes to legs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 ATORVASTATIN, HYDROCHLOROTHIAZIDE, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). On 12-Mar-2021, the patient experienced PRURITUS (Itchy from toes to legs) and RASH (Rash from toes to legs). On 13-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured) and ERYTHEMA (Reddish rash from toes to torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch and Rash, at a dose of UNK dosage form. At the time of the report, PRURITUS (Itchy from toes to legs), BURNING SENSATION (Burning sensation from rash), SWELLING (Bumps where rash has occured), ERYTHEMA (Reddish rash from toes to torso) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown and RASH (Rash from toes to legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The event reoccurred after being resolved when treated with Benadryl.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXAMETHASONE ACETATE (PLAVEX), RANOLAZINE (RANEXA) and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection). At the time of the report, INJECTION SITE RASH (Small rash at the site of injection) and INJECTION SITE PAIN (Soreness at the site of injection) outcome was unknown.            Additional concomitant medication reported was blood thinner for an unknown indication.  Treatment of events was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip pruritus, Lip swelling, Rash
Clinical narrative: lips swelling and sore; lips swelling and sore; lips itching; rash on every inch of her body; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of RASH (rash on every inch of her body), LIP SWELLING (lips swelling and sore), LIP PAIN (lips swelling and sore) and LIP PRURITUS (lips itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Cholesterol.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH (rash on every inch of her body). On 15-Mar-2021, the patient experienced LIP SWELLING (lips swelling and sore), LIP PAIN (lips swelling and sore) and LIP PRURITUS (lips itching). At the time of the report, RASH (rash on every inch of her body), LIP SWELLING (lips swelling and sore), LIP PAIN (lips swelling and sore) and LIP PRURITUS (lips itching) 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.   Concomitant medication use includes an unspecified cholesterol medication.   Treatment for the events included Benadryl, Medrol dose pack and an OTC anti-itch lotion.   It was noted that the patient had a doctor's appointment on 12Mar2021 after onset of the rash and lip itching.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dysphonia, Malaise
Clinical narrative: hoarseness; was not feeling well; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (hoarseness), MALAISE (was not feeling well) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Uterine cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 02-Mar-2021 to an unknown date for Uterine cancer, PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills). On 06-Mar-2021, the patient experienced MALAISE (was not feeling well). On an unknown date, the patient experienced DYSPHONIA (hoarseness). At the time of the report, DYSPHONIA (hoarseness) and CHILLS (chills) outcome was unknown and MALAISE (was not feeling well) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) elevation in blood pressure.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications include Blood Pressure Medications
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis
Clinical narrative: Pink eye; This spontaneous case was reported by a pharmacist and describes the occurrence of CONJUNCTIVITIS (Pink eye) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced CONJUNCTIVITIS (Pink eye). At the time of the report, CONJUNCTIVITIS (Pink eye) 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash; Hives from the waist up; Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives from the waist up), PRURITUS (Itching) and RASH (Rash) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (Hives from the waist up) and PRURITUS (Itching). On an unknown date, the patient experienced RASH (Rash). At the time of the report, URTICARIA (Hives from the waist up) and RASH (Rash) had resolved and PRURITUS (Itching) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication included steroid cream.  The action taken with mRNA-1273 with the events was considered as not applicable  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 events therefore, action taken with the drug in response to the events was not applicable.  The patient experienced a rash on the upper half of the body. From the waist up she described hives all her that part of body. She was having a sensitive skin and this happening in the past. It was itching at times but she was using a steroid cream that she had from a previous rash.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05-May-2021 included new event of rash added.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Delayed second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 PRODUCT DOSE OMISSION ISSUE (Delayed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delayed second dose) had resolved. 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 concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Upon follow-up receipt:contain non-significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Depression, Fatigue, Headache
Clinical narrative: depression; chills; nausea; headache; Fatigue; cough that was really intense for a short period; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that was really intense for a short period), DEPRESSION (depression), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. On 12-Feb-2021, COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, DEPRESSION (depression) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.    This case was linked to MOD-2021-044613 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: depression; chills; nausea; headache; Fatigue; cough that was really intense for a short period; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough that was really intense for a short period), DEPRESSION (depression), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0316201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. On 12-Feb-2021, COUGH (cough that was really intense for a short period), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, DEPRESSION (depression) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.    This case was linked to MOD-2021-044613 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Mess with your vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Mess with your vision) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Mess with your vision). At the time of the report, VISUAL IMPAIRMENT (Mess with your vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive second dose; A spontaneous report was received from an 85 year-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the second dose/missed dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   At the time of report, the patient had not received the second dose.   Action taken with mRNA-1273 in response to the event was not applicable; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot# (unknown), with no associated adverse events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling at injection site (Affected area was spreading around the arm and down); Rednessat the injection site (Affected area was spreading around the arm and down); Itchy/extremely itchy at injection site (Affected area was spreading around the arm and down); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy/extremely itchy at injection site (Affected area was spreading around the arm and down)), VACCINATION SITE SWELLING (swelling at injection site (Affected area was spreading around the arm and down)) and VACCINATION SITE ERYTHEMA (Rednessat the injection site (Affected area was spreading around the arm and down)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0025H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy/extremely itchy at injection site (Affected area was spreading around the arm and down)). On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site (Affected area was spreading around the arm and down)) and VACCINATION SITE ERYTHEMA (Rednessat the injection site (Affected area was spreading around the arm and down)). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy/extremely itchy at injection site (Affected area was spreading around the arm and down)), VACCINATION SITE SWELLING (swelling at injection site (Affected area was spreading around the arm and down)) and VACCINATION SITE ERYTHEMA (Rednessat the injection site (Affected area was spreading around the arm and down)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Certaline 50 mg Treatment included "Icing"
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye irritation, Fatigue, Ocular hyperaemia, Pain in extremity
Clinical narrative: "problems with her eyes"; sore arm; swollen on the lids; eyes are "red rimmed"; thinks it's conjunctivitis; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed") and CONJUNCTIVITIS (thinks it's conjunctivitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin) and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), VALSARTAN (DIOVAN), LEVOTHYROXINE SODIUM (SYNTHROID) and ALLOPURINOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired). At the time of the report, EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired) outcome was unknown. Not Provided          Treatment information does not provided. The action taken with the drug was not applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: "problems with her eyes"; sore arm; swollen on the lids; eyes are "red rimmed"; thinks it's conjunctivitis; tired; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed") and CONJUNCTIVITIS (thinks it's conjunctivitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin) and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), VALSARTAN (DIOVAN), LEVOTHYROXINE SODIUM (SYNTHROID) and ALLOPURINOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired). At the time of the report, EYE IRRITATION ("problems with her eyes"), PAIN IN EXTREMITY (sore arm), SWELLING OF EYELID (swollen on the lids), OCULAR HYPERAEMIA (eyes are "red rimmed"), CONJUNCTIVITIS (thinks it's conjunctivitis) and FATIGUE (tired) outcome was unknown. Not Provided          Treatment information does not provided. The action taken with the drug was not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose decreased
Clinical narrative: She checked her sugar and it was very low, it took 4-5 days until blood sugar level was normal; It took 4-5 days until blood sugar level was normal; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (She checked her sugar and it was very low, it took 4-5 days until blood sugar level was normal) and BLOOD GLUCOSE ABNORMAL (It took 4-5 days until blood sugar level was normal) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included LABETALOL, PREDNISONE, TACROLIMUS, METHIMAZOLE and CHLORTHALIDONE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (She checked her sugar and it was very low, it took 4-5 days until blood sugar level was normal) and BLOOD GLUCOSE ABNORMAL (It took 4-5 days until blood sugar level was normal). On 12-Mar-2021, BLOOD GLUCOSE DECREASED (She checked her sugar and it was very low, it took 4-5 days until blood sugar level was normal) and BLOOD GLUCOSE ABNORMAL (It took 4-5 days until blood sugar level was normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included eye drops.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Pruritus
Clinical narrative: sores itch; sores look like bubbles; sores on left side of body-lower back and around; achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sores itch), BLISTER (sores look like bubbles), PAIN (achy) and PAIN (sores on left side of body-lower back and around) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 041120A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (achy). On 14-Mar-2021, the patient experienced PRURITUS (sores itch) and PAIN (sores on left side of body-lower back and around). 14-Mar-2021, the patient experienced BLISTER (sores look like bubbles). At the time of the report, PRURITUS (sores itch), BLISTER (sores look like bubbles), PAIN (achy) and PAIN (sores on left side of body-lower back and around) had not resolved.            No concomitant medication use was provided by the reporter. No Treatment information reported.