chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sometimes gets stomach aches; she's not hungry; She's get down;not on a regular schedule and not living her normal life; first night everything was hurting / soreness in the arm from both shots that lasted about a week; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DECREASED APPETITE (she's not hungry), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches). 15-Apr-2021, the patient experienced DECREASED APPETITE (she's not hungry). At the time of the report, ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DECREASED APPETITE (she's not hungry), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 100 (High) 100.         Relevant concomitant medications were not reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-092344 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Head discomfort, Slow speech
Clinical narrative: pressure in head; heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest; Slow speech; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 30-Mar-2021, the patient experienced HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired). At the time of the report, HEAD DISCOMFORT (pressure in head), CHEST DISCOMFORT (heaviness in her chest,chest area hard and felt similar to when a steering wheel went into chest), SLOW SPEECH (Slow speech) and FATIGUE (tired) outcome was unknown. Not Provided          No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-092350 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Product administered to patient of inappropriate age
Clinical narrative: Product administered to patient of inappropriate age; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Type 1 Diabetes Mellitus).   On 01-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 10:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Product administered to patient of inappropriate age) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: (High) Hb1Ac is high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was  provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up was received Updated Reporter Information, Facility Information, Vaccine Dose Information and Patient Demographic details.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dysphagia, Erythema, Fatigue
Clinical narrative: Red spots on his forearms and tummy; Sick (left work mid-Day); In bed all day; Could Not Swallow Anything; Tired; Lungs Hurting; Burning Sensation in the Lungs; Throat and tongue hurting; Throat and tongue hurting; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting) and ILLNESS (Sick (left work mid-Day)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS and Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR UNSPEC) and FLUTICASONE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting), DYSPHAGIA (Could Not Swallow Anything) and FATIGUE (Tired). On 07-Apr-2021, the patient experienced ILLNESS (Sick (left work mid-Day)) and ASTHENIA (In bed all day). On 08-Apr-2021, the patient experienced ERYTHEMA (Red spots on his forearms and tummy). On 13-Apr-2021, ERYTHEMA (Red spots on his forearms and tummy) outcome was unknown. On 14-Apr-2021, PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting), ILLNESS (Sick (left work mid-Day)), ASTHENIA (In bed all day), DYSPHAGIA (Could Not Swallow Anything) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was Zyrtec, Advair disc inhaler  Consent received to save the caller's information wit in our database and for safety to follow up 27-APR-2021   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Illness, Oropharyngeal pain, Pulmonary pain
Clinical narrative: Red spots on his forearms and tummy; Sick (left work mid-Day); In bed all day; Could Not Swallow Anything; Tired; Lungs Hurting; Burning Sensation in the Lungs; Throat and tongue hurting; Throat and tongue hurting; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting) and ILLNESS (Sick (left work mid-Day)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS and Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR UNSPEC) and FLUTICASONE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting), DYSPHAGIA (Could Not Swallow Anything) and FATIGUE (Tired). On 07-Apr-2021, the patient experienced ILLNESS (Sick (left work mid-Day)) and ASTHENIA (In bed all day). On 08-Apr-2021, the patient experienced ERYTHEMA (Red spots on his forearms and tummy). On 13-Apr-2021, ERYTHEMA (Red spots on his forearms and tummy) outcome was unknown. On 14-Apr-2021, PULMONARY PAIN (Lungs Hurting), BURNING SENSATION (Burning Sensation in the Lungs), OROPHARYNGEAL PAIN (Throat and tongue hurting), GLOSSODYNIA (Throat and tongue hurting), ILLNESS (Sick (left work mid-Day)), ASTHENIA (In bed all day), DYSPHAGIA (Could Not Swallow Anything) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was Zyrtec, Advair disc inhaler  Consent received to save the caller's information wit in our database and for safety to follow up 27-APR-2021   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dehydration, Illness, Pain, Pyrexia
Clinical narrative: Body aches; altered vision; Anxiety; felt sick; fever; she was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick) and PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) 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 CHOLESTEROL for Cholesterol, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated). At the time of the report, PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes Gastritis medication along with above mentioned medications. No treatment drugs were reported.   This case was linked to MOD-2021-092346 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Body aches; altered vision; Anxiety; felt sick; fever; she was dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick) and PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21a) 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 CHOLESTEROL for Cholesterol, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated). At the time of the report, PAIN (Body aches), VISION BLURRED (altered vision), ANXIETY (Anxiety), ILLNESS (felt sick), PYREXIA (fever) and DEHYDRATION (she was dehydrated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes Gastritis medication along with above mentioned medications. No treatment drugs were reported.   This case was linked to MOD-2021-092346 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: deferred second dose; covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (deferred second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and XARELTO for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (positive). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. At the time of the report, COVID-19 (positive) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (deferred second dose) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: Positive Patient was tested positive for COVID on 03April2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Urticaria
Clinical narrative: whole body had hives; fever of 101.2 F; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (whole body had hives), PYREXIA (fever of 101.2 F) and NAUSEA (NAUSEA) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 041L20A) for COVID-19 vaccination.     NO MEDICAL HISTORY WAS PROVIDED.  Concomitant products included WARFARIN and PROPAFENONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced URTICARIA (whole body had hives). 01-Mar-2021, the patient experienced PYREXIA (fever of 101.2 F) and NAUSEA (NAUSEA). On 02-Mar-2021, NAUSEA (NAUSEA) had resolved. On 04-Mar-2021, URTICARIA (whole body had hives) and PYREXIA (fever of 101.2 F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) 101.2 F.         No treatment medication was reported.   This case was linked to MOD-2021-034757 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dental examination, Headache, Magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Caffeine allergy. Concomitant products included CALCIUM for Bone disorder NOS, MONASCUS PURPUREUS (RED YEAST RICE) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for Cholesterol, GLUCOSAMINE HYDROCHLORIDE and CHONDROITIN SULFATE for Joint ache, MAGNESIUM and COLECALCIFEROL (VIT D3) for Nutritional supplement, LEVOTHYROXINE for Thyroid disorder, ZINC and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache). 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, HEADACHE (Headache) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Dental examination: normal (Inconclusive) normal. On an unknown date, Magnetic resonance imaging: normal (normal) aging of blood vessel changes. On an unknown date, Ophthalmological examination: normal (Inconclusive) normal.         Action taken with mRNA-1273 in response to the events was not applicable. Patient stated getting 4 massages from acupuncturist Treatment medications included one pain shot For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: patient demographics updated , added medical history, added lab data, dosage regimen updated, concomitants was updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Feeling cold, Nausea
Clinical narrative: chilly; having pains; feeling very much dizzy; feeling to vomit; feeling nausea like you want to vomit; high temperature about 96.2,Temperature is high,temperature 102; joint is paining me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit) and PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included AMLODIPINE and CHOLESTEROL for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit), PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) and ARTHRALGIA (joint is paining me). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. At the time of the report, FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit), PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) and ARTHRALGIA (joint is paining me) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 and 96.2 (High) 96.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-168895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received and no new information was provided. On 25-May-2021: Follow up  was received and treatment medication was added. On 29-Jun-2021: Updated the outcome of events feeling cold, pain, dizziness, nausea, pyrexia and arthralgia from unknown to recovered/resolved.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chilly; having pains; feeling very much dizzy; feeling to vomit; feeling nausea like you want to vomit; high temperature about 96.2,Temperature is high,temperature 102; joint is paining me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit) and PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included AMLODIPINE and CHOLESTEROL for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit), PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) and ARTHRALGIA (joint is paining me). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at a dose of 1 dosage form. At the time of the report, FEELING COLD (chilly), PAIN (having pains), DIZZINESS (feeling very much dizzy), NAUSEA (feeling to vomit; feeling nausea like you want to vomit), PYREXIA (high temperature about 96.2,Temperature is high,temperature 102) and ARTHRALGIA (joint is paining me) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 and 96.2 (High) 96.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-168895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received and no new information was provided. On 25-May-2021: Follow up  was received and treatment medication was added. On 29-Jun-2021: Updated the outcome of events feeling cold, pain, dizziness, nausea, pyrexia and arthralgia from unknown to recovered/resolved.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: SARS Cov 2 infection after first dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine) in a patient of an unknown age and gender 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 26-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (SARS Cov 2 infection after first dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea
Clinical narrative: Sweating after second dose; a bit of nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating after second dose), NAUSEA (a bit of nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating after second dose), NAUSEA (a bit of nausea) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (Sweating after second dose), NAUSEA (a bit of nausea) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant details were provided No treatment details were provided
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Body temperature, Eye swelling, Headache, Mouth swelling
Clinical narrative: Allergic Reaction; swelling of the eyes; swelling of the mouth; facial swelling; patient crossed the window period for receiving the 2nd dose of vaccine; headache; fever of 104F, in ER fever of101F; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling) and PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling), PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine), HEADACHE (headache) and PYREXIA (fever of 104F, in ER fever of101F). The patient was treated with PREDNISONE for Allergic reaction, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling), HEADACHE (headache) and PYREXIA (fever of 104F, in ER fever of101F) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104F and 101 (High) 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  Treatment medications Oral steroid for 6 days  Patient was recommended to take Benadryl medication   This case was linked to MOD-2021-264306 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: No new information was added regarding first dose
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Swelling face
Clinical narrative: Allergic Reaction; swelling of the eyes; swelling of the mouth; facial swelling; patient crossed the window period for receiving the 2nd dose of vaccine; headache; fever of 104F, in ER fever of101F; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling) and PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling), PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine), HEADACHE (headache) and PYREXIA (fever of 104F, in ER fever of101F). The patient was treated with PREDNISONE for Allergic reaction, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (Allergic Reaction), EYE SWELLING (swelling of the eyes), MOUTH SWELLING (swelling of the mouth), SWELLING FACE (facial swelling), HEADACHE (headache) and PYREXIA (fever of 104F, in ER fever of101F) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient crossed the window period for receiving the 2nd dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104F and 101 (High) 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided  Treatment medications Oral steroid for 6 days  Patient was recommended to take Benadryl medication   This case was linked to MOD-2021-264306 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: No new information was added regarding first dose
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Cough, Inflammation, Lip exfoliation, Lip swelling
Clinical narrative: Inflammation; Swollen lips; Cracked lips; lips peeling; Tongue dark red; Dry cough; Rash; skin discoloration; skin peeling from bottom of feet; nail broken; redness mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling) and TONGUE ERYTHEMA (Tongue dark red) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth). At the time of the report, INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant information was not provided.  The treatment information was not provided.  The inflammation was on  80% of patients body.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Onychoclasis, Oral mucosal erythema, Rash, Skin discolouration, Skin exfoliation
Clinical narrative: Inflammation; Swollen lips; Cracked lips; lips peeling; Tongue dark red; Dry cough; Rash; skin discoloration; skin peeling from bottom of feet; nail broken; redness mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling) and TONGUE ERYTHEMA (Tongue dark red) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth). At the time of the report, INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant information was not provided.  The treatment information was not provided.  The inflammation was on  80% of patients body.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: Inflammation; Swollen lips; Cracked lips; lips peeling; Tongue dark red; Dry cough; Rash; skin discoloration; skin peeling from bottom of feet; nail broken; redness mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling) and TONGUE ERYTHEMA (Tongue dark red) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth). At the time of the report, INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant information was not provided.  The treatment information was not provided.  The inflammation was on  80% of patients body.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) 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 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Cough, Pyrexia, Vaccination complication
Clinical narrative: fever; weakness; Cough; felt mild symptoms/Symptoms worsened; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened), ASTHENIA (weakness) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient is reported to be diabetes.).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened). On 25-Apr-2021, the patient experienced COUGH (Cough). 25-Apr-2021, the patient experienced ASTHENIA (weakness). On 27-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, COUGH (Cough), VACCINATION COMPLICATION (felt mild symptoms/Symptoms worsened), ASTHENIA (weakness) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: high (High) Blood pressure was 203/50..         Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-Significant follow up updated on 29-Jun-2021 and email address updated for reporter/caregiver
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Rash
Clinical narrative: increase in blood pressure - 160/90; rash on both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increase in blood pressure - 160/90) and RASH (rash on both arms) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (increase in blood pressure - 160/90) and RASH (rash on both arms). The patient was treated with LOSARTAN POTASSIUM ongoing since an unknown date for Hypertension, at a dose of UNK dosage form. At the time of the report, BLOOD PRESSURE INCREASED (increase in blood pressure - 160/90) and RASH (rash on both arms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/90 (High) increased.           No Relevant concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Reporter requesting paper version of form  in mail On 04-Jun-2021: Additional information received on 04 JUNE 2021,Non-significant follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain in extremity
Clinical narrative: Soreness; Patient got COVID-19 after 1st dose of vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Soreness), COVID-19 (Patient got COVID-19 after 1st dose of vaccine) and FATIGUE (Fatigue) outcome was unknown. Not Provided      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 by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypersensitivity, Induration, Myalgia
Clinical narrative: Prickling/Tingling; Right arm swollen up; Hard like a brick; Redness/Erythema; Feeling hot; Arm sore just where shot was; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick) and ERYTHEMA (Redness/Erythema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction and Urticaria. Concurrent medical conditions included Hypertension (Condition improved now) since 18-Oct-2019, Diabetes mellitus (Condition good now) since 17-Dec-1985 and Drug allergy (Hives due to Codeine) since 1988. Concomitant products included INSULIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), METFORMIN HYDROCHLORIDE (METFORMIN ER), ATORVASTATIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) and LEVOFLOXACIN (LEVAQUIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at a dose of unknown and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of Unknown. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine.   This case was linked to MOD-2021-092451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added patient demographics, medical  history, new events and updated event outcome.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Prickling/Tingling; Right arm swollen up; Hard like a brick; Redness/Erythema; Feeling hot; Arm sore just where shot was; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick) and ERYTHEMA (Redness/Erythema) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypersensitivity reaction and Urticaria. Concurrent medical conditions included Hypertension (Condition improved now) since 18-Oct-2019, Diabetes mellitus (Condition good now) since 17-Dec-1985 and Drug allergy (Hives due to Codeine) since 1988. Concomitant products included INSULIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), METFORMIN HYDROCHLORIDE (METFORMIN ER), ATORVASTATIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) and LEVOFLOXACIN (LEVAQUIN) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at a dose of unknown and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of Unknown. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PARAESTHESIA (Prickling/Tingling), PERIPHERAL SWELLING (Right arm swollen up), INDURATION (Hard like a brick), ERYTHEMA (Redness/Erythema), FEELING HOT (Feeling hot) and MYALGIA (Arm sore just where shot was) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medicine.   This case was linked to MOD-2021-092451 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added patient demographics, medical  history, new events and updated event outcome.