chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site movement impairment
Clinical narrative: A lot of pain in the arm (left) where the injection was placed; Could not lift arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (A lot of pain in the arm (left) where the injection was placed) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift arm) 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.   Concomitant medication was not provided.  Treatment includes warm and cold compress alternately, aspirin cream on the area.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (minor arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030L20A) for COVID-19 immunization. No medical history information reported. On Jan 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 22, 2021, patient experienced pain in extremity (minor arm pain). At the time of the report, pain in extremity (minor arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Pain, Pruritus, Rash, Rash macular
Clinical narrative: Itching; Rash; Rash is hard to the touch; 3 red spots; Rash warm to the touch; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATENOLOL, ATORVASTATIN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN POTASSIUM (LOSARTIN) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch). On 05-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Itching; Rash; Rash is hard to the touch; 3 red spots; Rash warm to the touch; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ATENOLOL, ATORVASTATIN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN POTASSIUM (LOSARTIN) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch). On 05-Feb-2021, the patient experienced PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3 red spots), VACCINATION SITE WARMTH (Rash warm to the touch), PAIN (Pain), PRURITUS (Itching), RASH (Rash) and INJECTION SITE INDURATION (Rash is hard to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Malaise, Pain in extremity
Clinical narrative: feeling not well; headaches; pain at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (feeling not well), HEADACHE (headaches) and INJECTION SITE PAIN (pain at the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 10-Feb-2021, the patient experienced MALAISE (feeling not well), HEADACHE (headaches) and INJECTION SITE PAIN (pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (feeling not well) and HEADACHE (headaches) was resolving and INJECTION SITE PAIN (pain at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reactions) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic reactions). At the time of the report, HYPERSENSITIVITY (allergic reactions) 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 101.9F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101.9F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (fever 101.9F). At the time of the report, PYREXIA (fever 101.9F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: (High) 101.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after vaccination; flu like/cold like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like/cold like symptoms) and COVID-19 (tested positive for COVID-19 after vaccination) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like/cold like symptoms). On 12-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19 after vaccination). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (flu like/cold like symptoms) had resolved. At the time of the report, COVID-19 (tested positive for COVID-19 after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: (Positive) Positive.     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.   Concomitant medications reported were Medication for hypertension. No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19). At the time of the report, COVID-19 (Diagnosed with positive COVID-19 a couple of days after receiving the Moderna COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Impetigo, Vaccination site pain
Clinical narrative: Impetigo; Sore arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of IMPETIGO (Impetigo) and VACCINATION SITE PAIN (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 12-Feb-2021, the patient experienced IMPETIGO (Impetigo). On 11-Feb-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, IMPETIGO (Impetigo) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm at the injection arm; itches at the injection arm; Redness at the injection arm; Swelling at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm). At the time of the report, VACCINATION SITE WARMTH (Warm at the injection arm), VACCINATION SITE PRURITUS (itches at the injection arm), VACCINATION SITE ERYTHEMA (Redness at the injection arm) and VACCINATION SITE SWELLING (Swelling at the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with Covid19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid19) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with Covid19). At the time of the report, COVID-19 (diagnosed with Covid19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Herpes zoster, Myalgia
Clinical narrative: Shingles; bright red rash on the abdomen; severe stomach cramps; body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. On 12-Feb-2021, RASH ERYTHEMATOUS (bright red rash on the abdomen) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved and ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) had not resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received on 19-jun-2021, event shingles was added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Shingles; bright red rash on the abdomen; severe stomach cramps; body aches; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012L20A) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (bright red rash on the abdomen), ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). On 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. On 12-Feb-2021, RASH ERYTHEMATOUS (bright red rash on the abdomen) had resolved. At the time of the report, HERPES ZOSTER (Shingles) had resolved and ABDOMINAL PAIN UPPER (severe stomach cramps), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) had not resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received on 19-jun-2021, event shingles was added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) had not resolved. Not Provided          No concomitant medications were reported.  No treatment information was reported.    Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Migraine, Product dose omission issue
Clinical narrative: migraine; first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot; Swollen (Right Lip); This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen (Right Lip)), MIGRAINE (migraine) and PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced LIP SWELLING (Swollen (Right Lip)). On 04-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, LIP SWELLING (Swollen (Right Lip)) had not resolved, MIGRAINE (migraine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided. patients  reaction on the side of her lip is still going on. She has been to doctors and MRI/CT-Scan shows everything is normal.  She states that she would like to receive the second dose of the COVID-19 vaccine but nobody is willing to give it to her because of her reaction.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 contained: Updated contact details- Email ID; On 04-Aug-2021: Follow-up received: Event added
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling
Clinical narrative: Left arm (the whole arm) is swollen; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache). At the time of the report, PERIPHERAL SWELLING (Left arm (the whole arm) is swollen) and HEADACHE (Severe headache) 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. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Excruciating headache; Chills; Fatigue; Slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Excruciating headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea) in a 49-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 ESCITALOPRAM OXALATE (LEXAPRO), BUPROPION HYDROCHLORIDE (WELLBUTRIN), MAGNESIUM, DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]), MULTIVITAMINS [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and FERRIC CARBOXYMALTOSE (INJECTAFER) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Excruciating headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Slight nausea) had resolved. At the time of the report, HEADACHE (Excruciating headache) had not resolved. Not Provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red rash in her injection arm; Red rash in her injection arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm). At the time of the report, VACCINATION SITE PRURITUS (Red rash in her injection arm) and VACCINATION SITE ERYTHEMA (Red rash in her injection arm) outcome was unknown. Not Provided      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 relevant Concomitant medications were reported. No Treatment for the event was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site erythema, Pruritus
Clinical narrative: itching; hot to touch; injection site red circles; local redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (local redness), PRURITUS (itching), FEELING HOT (hot to touch) and INJECTION SITE ERYTHEMA (injection site red circles) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin, Skin disorder NOS and Allergy to antibiotic.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (local redness). On 06-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red circles). On 12-Feb-2021, the patient experienced PRURITUS (itching) and FEELING HOT (hot to touch). On 10-Feb-2021, INJECTION SITE ERYTHEMA (injection site red circles) had resolved. At the time of the report, ERYTHEMA (local redness) outcome was unknown and PRURITUS (itching) and FEELING HOT (hot to touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: The event little more red. itching again, as reoccurred its not coded, its mentioned in the narrative
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got Covid between the first and second shot,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid between the first and second shot,) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got Covid between the first and second shot,). At the time of the report, COVID-19 (got Covid between the first and second shot,) outcome was unknown.            No concomitant medications were given No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Additional information received
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects Post first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects Post first dose) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects Post first dose). At the time of the report, VACCINATION COMPLICATION (Side effects Post first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: unspecified adverse event as reported
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Chills, Headache, Respiratory tract congestion
Clinical narrative: Congestion; Warm Eyes; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, SARS-CoV-2 test
Clinical narrative: Change in taste sense; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Change in taste sense) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Change in taste sense). At the time of the report, DYSGEUSIA (Change in taste sense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  On an unknown date, the patient experienced change in taste sense. The patient has done multiple COVID tests with results returned negative. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site scar
Clinical narrative: Red rash on vaccination site; Rash has spread into a circle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (Rash has spread into a circle) and VACCINATION SITE RASH (Red rash on vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE SCAR (Rash has spread into a circle). On an unknown date, the patient experienced VACCINATION SITE RASH (Red rash on vaccination site). At the time of the report, VACCINATION SITE SCAR (Rash has spread into a circle) and VACCINATION SITE RASH (Red rash on vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling
Clinical narrative: Left ear feels numb; Side of face feels numb; Numbness in lips, lips still feel numb; lips felt swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips felt swollen), HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb), HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concomitant products included PITAVASTATIN CALCIUM (LIVALO) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LIP SWELLING (lips felt swollen) and HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb). On 12-Feb-2021, the patient experienced HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN EXTRA) for Adverse event, at a dose of UNK dosage form. At the time of the report, LIP SWELLING (lips felt swollen), HYPOAESTHESIA (Side of face feels numb) and HYPOAESTHESIA (Left ear feels numb) outcome was unknown and HYPOAESTHESIA ORAL (Numbness in lips, lips still feel numb) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 100.2 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.2 Fahrenheit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever 100.2 Fahrenheit). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100.2 Fahrenheit) outcome was unknown.            No relevant concomitant medications were reported.     This case was linked to MOD-2021-044128 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Vaccination site pain
Clinical narrative: blood pressure is fine, actually is low; fast heartbeat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), HEART RATE INCREASED (fast heartbeat) and HYPOTENSION (blood pressure is fine, actually is low) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 11-Feb-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). On an unknown date, the patient experienced HYPOTENSION (blood pressure is fine, actually is low). On 12-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, HEART RATE INCREASED (fast heartbeat) and HYPOTENSION (blood pressure is fine, actually is low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details included medications for hypertension and allergies. Treatment details was not reported by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid-19 two and a half weeks ago with just mild symptoms.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) had not resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot Arm at injection site; Puffy Arm (Injection Site); Red at injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot Arm at injection site), VACCINATION SITE SWELLING (Puffy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Red at injection Site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot Arm at injection site), VACCINATION SITE SWELLING (Puffy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Red at injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot Arm at injection site), VACCINATION SITE SWELLING (Puffy Arm (Injection Site)) and VACCINATION SITE ERYTHEMA (Red at injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site reaction
Clinical narrative: Fever; It's gotten bigger, pinkish, kind of a rash but not really a rash; Soreness all over, generally rotten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, VACCINATION SITE REACTION (It's gotten bigger, pinkish, kind of a rash but not really a rash), PAIN (Soreness all over, generally rotten), CHILLS (Chills) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Outcome of event (s) changed from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide; Little sore - on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm) 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 VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm). At the time of the report, VACCINATION SITE RASH (Rash on arm 10-11 days since getting the vaccine, getting bigger 4 inches long and 2 inches wide) and VACCINATION SITE PAIN (Little sore - on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Outcome of the events updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vaccination site rash
Clinical narrative: Injection site gotten bigger, pinkish, kind of a rash but not really a rash; diarrhea; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (low grade fever) and VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and PYREXIA (low grade fever). On an unknown date, the patient experienced VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (low grade fever) and VACCINATION SITE RASH (Injection site gotten bigger, pinkish, kind of a rash but not really a rash) outcome was unknown.            No concomitant information was reported. Treatment information was not reported.   This case was linked to MOD-2021-034765 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: her arm started to itch; arm started to itch was bright red; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Celiac disease (Medical history reported as medical condition as celiac disease).    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 VACCINATION SITE PRURITUS (Itching at the injection), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Her arm is all red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), OXYCODONE and ACETAMINOPHEN for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.