chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Limb discomfort
Clinical narrative: feeling tired and fatigued again; red lump noted at the injection site; red lump noted at the injection site; on and off tiredness, tired and fatigued; R arm was hurting; burning sensation at the injection site; arm sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning sensation at the injection site), FATIGUE (on and off tiredness, tired and fatigued), PAIN IN EXTREMITY (arm sore and achy), LIMB DISCOMFORT (R arm was hurting) and INJECTION SITE ERYTHEMA (red lump noted at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE PAIN (burning sensation at the injection site) and PAIN IN EXTREMITY (arm sore and achy). On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (R arm was hurting). On 31-Jan-2021, the patient experienced FATIGUE (on and off tiredness, tired and fatigued), INJECTION SITE ERYTHEMA (red lump noted at the injection site) and INJECTION SITE MASS (red lump noted at the injection site). On 01-Feb-2021, the patient experienced FATIGUE (feeling tired and fatigued again). On 23-Jan-2021, INJECTION SITE PAIN (burning sensation at the injection site) and PAIN IN EXTREMITY (arm sore and achy) had resolved. At the time of the report, FATIGUE (on and off tiredness, tired and fatigued), LIMB DISCOMFORT (R arm was hurting), INJECTION SITE ERYTHEMA (red lump noted at the injection site), INJECTION SITE MASS (red lump noted at the injection site) and FATIGUE (feeling tired and fatigued again) 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 concomitants or treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feeling tired and fatigued again; red lump noted at the injection site; red lump noted at the injection site; on and off tiredness, tired and fatigued; R arm was hurting; burning sensation at the injection site; arm sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning sensation at the injection site), FATIGUE (on and off tiredness, tired and fatigued), PAIN IN EXTREMITY (arm sore and achy), LIMB DISCOMFORT (R arm was hurting) and INJECTION SITE ERYTHEMA (red lump noted at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE PAIN (burning sensation at the injection site) and PAIN IN EXTREMITY (arm sore and achy). On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (R arm was hurting). On 31-Jan-2021, the patient experienced FATIGUE (on and off tiredness, tired and fatigued), INJECTION SITE ERYTHEMA (red lump noted at the injection site) and INJECTION SITE MASS (red lump noted at the injection site). On 01-Feb-2021, the patient experienced FATIGUE (feeling tired and fatigued again). On 23-Jan-2021, INJECTION SITE PAIN (burning sensation at the injection site) and PAIN IN EXTREMITY (arm sore and achy) had resolved. At the time of the report, FATIGUE (on and off tiredness, tired and fatigued), LIMB DISCOMFORT (R arm was hurting), INJECTION SITE ERYTHEMA (red lump noted at the injection site), INJECTION SITE MASS (red lump noted at the injection site) and FATIGUE (feeling tired and fatigued again) 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 concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain in extremity
Clinical narrative: soreness in her lymph node under her arm and 1-2 complained with sore lymph nodes similar to hers; they had a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (soreness in her lymph node under her arm and 1-2 complained with sore lymph nodes similar to hers) and PAIN IN EXTREMITY (they had a little bit of a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (soreness in her lymph node under her arm and 1-2 complained with sore lymph nodes similar to hers) and PAIN IN EXTREMITY (they had a little bit of a sore arm). At the time of the report, LYMPH NODE PAIN (soreness in her lymph node under her arm and 1-2 complained with sore lymph nodes similar to hers) and PAIN IN EXTREMITY (they had a little bit of a sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided. No concomitant medications were reported   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Vaccination site pain, Vertigo
Clinical narrative: Soreness in the arm; dizzy; feels like everything is spinning around and stops, and then starts again; arm pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), VERTIGO (feels like everything is spinning around and stops, and then starts again), VACCINATION SITE PAIN (arm pain at the injection site) and MYALGIA (Soreness in the arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia and Osteoporosis. Concomitant products included ATORVASTATIN, LORAZEPAM, ATORVASTATIN CALCIUM (LIPITOR) and VITAMINS NOS for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain at the injection site). On 03-Feb-2021, the patient experienced DIZZINESS (dizzy) and VERTIGO (feels like everything is spinning around and stops, and then starts again). On an unknown date, the patient experienced MYALGIA (Soreness in the arm). At the time of the report, DIZZINESS (dizzy), VERTIGO (feels like everything is spinning around and stops, and then starts again) and VACCINATION SITE PAIN (arm pain at the injection site) had resolved and MYALGIA (Soreness in the arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included cholesterol medication, osteoporosis injection in every 6 month and lucartamide for unknown indication. No treatment details were added.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received contains patient's address details. On 19-Jul-2021: Follow up received. Updated new non serious event as sore arm.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: he noticed the area seems warm, red, and swelling; he noticed the area seems warm, red, and swelling; he noticed the area seems warm, red, and swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of injection site warmth (he noticed the area seems warm, red, and swelling), Injection site erythema (he noticed the area seems warm, red, and swelling) and injection site swelling(he noticed the area seems warm, red, and swelling)   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    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 describes the occurrence of injection site warmth (he noticed the area seems warm, red, and swelling), Injection site erythema (he noticed the area seems warm, red, and swelling) and injection site swelling(he noticed the area seems warm, red, and swelling).The outcome of  injection site warmth (he noticed the area seems warm, red, and swelling), Injection site erythema (he noticed the area seems warm, red, and swelling) and injection site swelling(he noticed the area seems warm, red, and swelling) is unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: trouble breathing; short breaths; couldn't breath well; throwed up; bones hurt; chills; super shaky; really sweating; really sick; sore arm; tired; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing) and RESPIRATORY RATE DECREASED (short breaths) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (really sick), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating). At the time of the report, ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative:.     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.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypopnoea, Illness, Nervousness, Pain in extremity, Respiratory rate decreased
Clinical narrative: trouble breathing; short breaths; couldn't breath well; throwed up; bones hurt; chills; super shaky; really sweating; really sick; sore arm; tired; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing) and RESPIRATORY RATE DECREASED (short breaths) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (really sick), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating). At the time of the report, ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative:.     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.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: trouble breathing; short breaths; couldn't breath well; throwed up; bones hurt; chills; super shaky; really sweating; really sick; sore arm; tired; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing) and RESPIRATORY RATE DECREASED (short breaths) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (really sick), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating). At the time of the report, ILLNESS (really sick), PAIN IN EXTREMITY (sore arm), FATIGUE (tired), DYSPNOEA (trouble breathing), RESPIRATORY RATE DECREASED (short breaths), HYPOPNOEA (couldn't breath well), VOMITING (throwed up), BONE PAIN (bones hurt), CHILLS (chills), NERVOUSNESS (super shaky) and HYPERHIDROSIS (really sweating) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative:.     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.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: muscle pain; chills; 101.8°F fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (101.8°F fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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 01-Jan-2021, the patient experienced MYALGIA (muscle pain), CHILLS (chills) and PYREXIA (101.8°F fever). On 02-Jan-2021, CHILLS (chills) and PYREXIA (101.8°F fever) had resolved. At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were 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 these events, 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 these events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives on Chest, between shoulder and neck area, upper back / Hives on stomach and lower back; Redness; Itching; A spontaneous report was received from a Consumer concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hives on chest, between shoulder and neck area, upper back / urticaria, redness / erythema, itching / pruritus, hives on stomach and lower back / urticaria.  The patient's medical history was not provided. Concomitant medications reported were Warfarin: 9 mg Once day for drug use for unknown indication.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Jan 2021, upon 40 minutes after vaccination, the patient broke out in hives that some on the chest, between shoulder and neck area, upper back, redness and itchiness. The patient took Diphenhydramine liquid about 20mg (7.5ml) at 2pm. When the medicine started to wear off, the patient had hives on stomach, lower back, redness and itchiness. So again took Diphenhydramine (7.5ml) at 11pm. Then the small hives started to subside and the larger ones subsided one day after.  Treatment details included Diphenhydramine 20 mg: 7.5 mL at 2 pm. 7.5 mL again at 11 pm on 25Jan2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events hives on chest, between shoulder and neck area, upper back, redness, itching and hives on stomach and lower back was resolved on 27 Jan 2021.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Sore arm; Red bumps on arm; a rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm). On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 31-Jan-2021, INJECTION SITE SWELLING (Red bumps on arm) and INJECTION SITE RASH (a rash on her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema
Clinical narrative: a pear shaped red sport at the injection; a little bit of soreness at the injection; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (a little bit of soreness at the injection) and VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (a little bit of soreness at the injection). On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection). On 17-Jan-2021, INJECTION SITE PAIN (a little bit of soreness at the injection) had resolved. On 29-Jan-2021, VACCINATION SITE ERYTHEMA (a pear shaped red sport at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Report any AE after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Report any AE after 2nd 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Report any AE after 2nd dose). At the time of the report, ADVERSE DRUG REACTION (Report any AE after 2nd dose) outcome was unknown. Not Provided          No concomitant medication were provided by reporter.  No treatment was reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Hypersensitivity, Rash pruritic
Clinical narrative: Very severe allergic reaction; Very itchy rash in the back at night; Hot blushes; Chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Very severe allergic reaction), RASH PRURITIC (Very itchy rash in the back at night), HOT FLUSH (Hot blushes) and CHILLS (Chills) 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.   Other concomitant medications included: Medication for high blood pressure.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of severe allergic reaction with pruritic rash, chills and hot flushes, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cyst
Clinical narrative: Bump on her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE CYST (Bump on her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 INJECTION SITE CYST (Bump on her arm). At the time of the report, INJECTION SITE CYST (Bump on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.        No relevant concomitant medications were reported  Treatment details included Benadryl, it didn't help.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch sensation; Itchy Sensation; Redness; Swelling; Pain near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2021, VACCINATION SITE WARMTH (Hot to touch sensation), VACCINATION SITE PRURITUS (Itchy Sensation), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Pain near the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm a little sore; A spontaneous report was received from a consumer concerning a  female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm a little sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) arm a little sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm a little sore was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Injection site inflammation, Pruritus, Scratch
Clinical narrative: very terrible reaction; totally allergic to everything; scratched/scrachted herself to death; itched; was beginning to swell up; Hives on arms and hands; diarrhea; Inflammation of both arms; Itching of both arms/some itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation of both arms), DIARRHOEA (diarrhea), VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything) and SCRATCH (scratched/scrachted herself to death) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concomitant products included ALLIUM SATIVUM (GARLIC NATURAL) 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 20-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation of both arms) and VACCINATION SITE PRURITUS (Itching of both arms/some itching). On 21-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives on arms and hands). On an unknown date, the patient experienced VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything), SCRATCH (scratched/scrachted herself to death), PRURITUS (itched) and SWELLING (was beginning to swell up). At the time of the report, INJECTION SITE INFLAMMATION (Inflammation of both arms), DIARRHOEA (diarrhea), VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything), SCRATCH (scratched/scrachted herself to death), SWELLING (was beginning to swell up), VACCINATION SITE PRURITUS (Itching of both arms/some itching) and VACCINATION SITE URTICARIA (Hives on arms and hands) outcome was unknown and PRURITUS (itched) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient received antihistamine 30-40 minutes before she took the second dose. for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) ,the reporter did not provide any causality assessment.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pruritus, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: very terrible reaction; totally allergic to everything; scratched/scrachted herself to death; itched; was beginning to swell up; Hives on arms and hands; diarrhea; Inflammation of both arms; Itching of both arms/some itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation of both arms), DIARRHOEA (diarrhea), VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything) and SCRATCH (scratched/scrachted herself to death) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concomitant products included ALLIUM SATIVUM (GARLIC NATURAL) 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 20-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation of both arms) and VACCINATION SITE PRURITUS (Itching of both arms/some itching). On 21-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 31-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives on arms and hands). On an unknown date, the patient experienced VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything), SCRATCH (scratched/scrachted herself to death), PRURITUS (itched) and SWELLING (was beginning to swell up). At the time of the report, INJECTION SITE INFLAMMATION (Inflammation of both arms), DIARRHOEA (diarrhea), VACCINATION SITE REACTION (very terrible reaction), HYPERSENSITIVITY (totally allergic to everything), SCRATCH (scratched/scrachted herself to death), SWELLING (was beginning to swell up), VACCINATION SITE PRURITUS (Itching of both arms/some itching) and VACCINATION SITE URTICARIA (Hives on arms and hands) outcome was unknown and PRURITUS (itched) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient received antihistamine 30-40 minutes before she took the second dose. for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) ,the reporter did not provide any causality assessment.    Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Arm has been very stiff and uncomfortable since; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm has been very stiff and uncomfortable since) 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 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm has been very stiff and uncomfortable since). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm has been very stiff and uncomfortable since) 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: This case concerns a female of unknown age with NS unexpected musculoskeletal stiffness.  Treatment not reported.  Event outcomes unknown. Based on the current available information and temporal association between use of the product and the start date of the musculoskeletal stiffness, a causal relationship cannot be excluded
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Erythema, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PRURITUS (Itching), ERYTHEMA (Redness was a 3x2 inch spot), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis since 2016. On 21-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 9:00 AM, the patient experienced PERIPHERAL SWELLING (Swollen) and ERYTHEMA (Redness was a 3x2 inch spot). 28-Jan-2021 at 9:00 AM, the patient experienced PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction). On 06-Feb-2021 at 9:00 AM, PERIPHERAL SWELLING (Swollen), PRURITUS (Itching), ERYTHEMA (Redness was a 3x2 inch spot), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 97.6 (Inconclusive) 97.6. On 29-Jan-2021, Body temperature: 97.2 (Inconclusive) 97.2. On 30-Jan-2021, Blood pressure measurement: 101/62 (Inconclusive) 101/62. On 30-Jan-2021, Body temperature: 97.6 (Inconclusive) 97.6. On 30-Jan-2021, Respiratory rate: 12 (Inconclusive) 12. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient reported that repeated icing of the area reduced the swelling and redness. This case was linked to MOD-2021-250949. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up was received on 8-JULY-2021  and patient information updated, event added and event outcomes updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PRURITUS (Itching), ERYTHEMA (Redness was a 3x2 inch spot), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis since 2016. On 21-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 9:00 AM, the patient experienced PERIPHERAL SWELLING (Swollen) and ERYTHEMA (Redness was a 3x2 inch spot). 28-Jan-2021 at 9:00 AM, the patient experienced PRURITUS (Itching), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction). On 06-Feb-2021 at 9:00 AM, PERIPHERAL SWELLING (Swollen), PRURITUS (Itching), ERYTHEMA (Redness was a 3x2 inch spot), VACCINATION SITE SWELLING (Swelling of the injection site) and VACCINATION SITE ERYTHEMA (Allergic injection site reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 97.6 (Inconclusive) 97.6. On 29-Jan-2021, Body temperature: 97.2 (Inconclusive) 97.2. On 30-Jan-2021, Blood pressure measurement: 101/62 (Inconclusive) 101/62. On 30-Jan-2021, Body temperature: 97.6 (Inconclusive) 97.6. On 30-Jan-2021, Respiratory rate: 12 (Inconclusive) 12. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient reported that repeated icing of the area reduced the swelling and redness. This case was linked to MOD-2021-250949. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up was received on 8-JULY-2021  and patient information updated, event added and event outcomes updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm was tender to touch; Arm got really red with the reaction being around 2-3 inches; Itched a little bit; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm was tender to touch), VACCINATION SITE ERYTHEMA (Arm got really red with the reaction being around 2-3 inches) and VACCINATION SITE PRURITUS (Itched a little bit) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0255202A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 TENDERNESS (Arm was tender to touch), VACCINATION SITE ERYTHEMA (Arm got really red with the reaction being around 2-3 inches) and VACCINATION SITE PRURITUS (Itched a little bit). On 25-Jan-2021, TENDERNESS (Arm was tender to touch), VACCINATION SITE ERYTHEMA (Arm got really red with the reaction being around 2-3 inches) and VACCINATION SITE PRURITUS (Itched a little bit) had resolved.        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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: body aches; nausea; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Nephritis and Allergy to antibiotic (IV antibiotic (rash)).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Feb-2021, the patient experienced PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (body aches), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Treatment details included Advil.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Fatigue; Shaking; Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 28-Jan-2021, the patient experienced TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 29-Jan-2021, the patient experienced FATIGUE (Fatigue). On 28-Jan-2021, TREMOR (Shaking), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 29-Jan-2021, FATIGUE (Fatigue) had resolved.       This case was linked to MOD21-017077 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient took second dose and stated no need for further follow up
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Induration, Lethargy
Clinical narrative: Arm burning and hot; Arm stinging; itchy; hard arm; felt like my throat might of been a little swollen; Arm was swollen/puffy; Felt terrible; Tired; lethargic; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (felt like my throat might of been a little swollen), PERIPHERAL SWELLING (Arm was swollen/puffy), FEELING ABNORMAL (Felt terrible), SKIN BURNING SENSATION (Arm burning and hot) and PAIN (Arm stinging) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen/puffy), FEELING ABNORMAL (Felt terrible), LETHARGY (lethargic), ERYTHEMA (Red arm) and FATIGUE (Tired). On 24-Jan-2021, the patient experienced PHARYNGEAL SWELLING (felt like my throat might of been a little swollen). On 30-Jan-2021, the patient experienced SKIN BURNING SENSATION (Arm burning and hot), PAIN (Arm stinging), PRURITUS (itchy) and INDURATION (hard arm). On 23-Jan-2021, FEELING ABNORMAL (Felt terrible) had resolved. On 27-Jan-2021, PHARYNGEAL SWELLING (felt like my throat might of been a little swollen) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm was swollen/puffy), SKIN BURNING SENSATION (Arm burning and hot), PAIN (Arm stinging), LETHARGY (lethargic), ERYTHEMA (Red arm), PRURITUS (itchy), INDURATION (hard arm) and FATIGUE (Tired) outcome was unknown.            Concomitant medications were not provided.  Treatment medications included antihistamines for swelling and itching.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.