chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Patient reported headache 3 days after receiving 2nd dose; felt tired; Patient started experiencing shaking, chills, aching, sore body and pain same day at night after; Patient started experiencing chills same day at night after receiving 2nd dose; Patient started experiencing shaking same day at night after receiving 2nd dose; Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and FATIGUE (felt tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 03-Mar-2021, the patient experienced TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after). On 04-Mar-2021, the patient experienced FATIGUE (felt tired). On 06-Mar-2021, the patient experienced HEADACHE (Patient reported headache 3 days after receiving 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TREMOR (Patient started experiencing shaking same day at night after receiving 2nd dose), PAIN (Patient started experiencing aching/ sore body/ pain same day at night after receiving 2nd dose), HEADACHE (Patient reported headache 3 days after receiving 2nd dose), CHILLS (Patient started experiencing chills same day at night after receiving 2nd dose), FATIGUE (felt tired) and MYALGIA (Patient started experiencing shaking, chills, aching, sore body and pain same day at night after) outcome was unknown.            Concomitant medication : Thyroid medication
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain
Clinical narrative: little hard at the injection site; little pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (little hard at the injection site) and INJECTION SITE PAIN (little pain at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE INDURATION (little hard at the injection site) and INJECTION SITE PAIN (little pain at the injection site). On 07-Mar-2021, INJECTION SITE INDURATION (little hard at the injection site) and INJECTION SITE PAIN (little pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History was provided by Reporter. No Concomitant Medications were  provided by Reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Fatigue, Feeling of body temperature change, Nausea
Clinical narrative: Clammy with no temperature; No appetite; Hot & Cold; Nausea; Very Tired; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy with no temperature), DECREASED APPETITE (No appetite), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold), NAUSEA (Nausea) and FATIGUE (Very Tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced COLD SWEAT (Clammy with no temperature), DECREASED APPETITE (No appetite), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold), NAUSEA (Nausea) and FATIGUE (Very Tired). At the time of the report, COLD SWEAT (Clammy with no temperature), DECREASED APPETITE (No appetite), FEELING OF BODY TEMPERATURE CHANGE (Hot & Cold), NAUSEA (Nausea) and FATIGUE (Very Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: On and off pounding in head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (On and off pounding in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 11-Feb-2021, the patient experienced HEADACHE (On and off pounding in head). On 11-Feb-2021, HEADACHE (On and off pounding in head) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hunger, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Very hungry; Swelling at the injection site; Pain at the injection site; Muscle Pain; Tiredness or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Very hungry), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue). On 07-Mar-2021, the patient experienced HUNGER (Very hungry). On 06-Mar-2021, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue) had resolved. At the time of the report, HUNGER (Very hungry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Rough time breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Rough time breathing) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included End stage COPD and Sleep apnea. Concomitant products included PREDNISONE for an unknown indication.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Rough time breathing). The patient was treated with PREDNISONE for Dyspnoea, at an unspecified dose and frequency. On 07-Mar-2021, DYSPNOEA (Rough time breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 20 May 2021, the age was corrected to 71 years.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: Shortness of breath; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 DYSPNOEA (Shortness of breath) and NAUSEA (nausea). At the time of the report, DYSPNOEA (Shortness of breath) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Headache, Injection site erythema, Pain, Pain in extremity
Clinical narrative: it felt like a bee sting with the stinger left in; with a little bit of swelling; skin feels "rough" to the touch; sore arm; Headache; arm felt itchy; felt like a bee sting with the stinger left in in and a rash; 4 inches below the injection site there was redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling) and DRY SKIN (skin feels "rough" to the touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (arm felt itchy), RASH (felt like a bee sting with the stinger left in in and a rash) and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), DRY SKIN (skin feels "rough" to the touch) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), RASH (felt like a bee sting with the stinger left in in and a rash) and HEADACHE (Headache) outcome was unknown and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-117738, MOD-2021-117738.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Details of 1st and 2nd dose AEs
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: it felt like a bee sting with the stinger left in; with a little bit of swelling; skin feels "rough" to the touch; sore arm; Headache; arm felt itchy; felt like a bee sting with the stinger left in in and a rash; 4 inches below the injection site there was redness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling) and DRY SKIN (skin feels "rough" to the touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (arm felt itchy), RASH (felt like a bee sting with the stinger left in in and a rash) and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), DRY SKIN (skin feels "rough" to the touch) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (arm felt itchy), PAIN (it felt like a bee sting with the stinger left in), SWELLING (with a little bit of swelling), RASH (felt like a bee sting with the stinger left in in and a rash) and HEADACHE (Headache) outcome was unknown and INJECTION SITE ERYTHEMA (4 inches below the injection site there was redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-117738, MOD-2021-117738.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Details of 1st and 2nd dose AEs
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Muscular weakness, Nausea, Vaccination site induration
Clinical narrative: Weak legs after 2nd dose; Terrible headache after 2nd dose; Nausea after 2nd dose; Swelling at injection site after 2nd dose; Slight diarrhea after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BENRALIZUMAB (FASENRA) for Asthma.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Slight diarrhea after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose). On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose). On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak legs after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose), VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose), VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Weak legs after 2nd dose; Terrible headache after 2nd dose; Nausea after 2nd dose; Swelling at injection site after 2nd dose; Slight diarrhea after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; Large, hard itchy lump after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included BENRALIZUMAB (FASENRA) for Asthma.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Slight diarrhea after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose) and VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose). On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose). On 27-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak legs after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Slight diarrhea after 2nd dose), MUSCULAR WEAKNESS (Weak legs after 2nd dose), VACCINATION SITE MASS (Large, hard itchy lump after 2nd dose), VACCINATION SITE INDURATION (Large, hard itchy lump after 2nd dose), VACCINATION SITE PRURITUS (Large, hard itchy lump after 2nd dose), VACCINATION SITE SWELLING (Swelling at injection site after 2nd dose), HEADACHE (Terrible headache after 2nd dose) and NAUSEA (Nausea after 2nd dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20H and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Viral syndrome ((chronic-peak and viral syndromes)). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided were blood pressure medication nd antiviral drugs. Treatment medication provided were Tylenol.   Follow-up received on 5-May-2021 included no new information.   This case was linked to MOD-2021-037430 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up was received on 5-May-2021 with NNI.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Heart rate
Clinical narrative: loss of appetite; weakness; dizziness; the whole body was aching so bad that wanted to cry; severe head ache; nausea; woke up with slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry) and HEADACHE (severe head ache) in a 68-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.     The patient's past medical history included COVID-19 on 13-Nov-2020. Concurrent medical conditions included COPD and Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever). At the time of the report, DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased heart beats per minute (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: loss of appetite; weakness; dizziness; the whole body was aching so bad that wanted to cry; severe head ache; nausea; woke up with slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry) and HEADACHE (severe head ache) in a 68-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.     The patient's past medical history included COVID-19 on 13-Nov-2020. Concurrent medical conditions included COPD and Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever). At the time of the report, DECREASED APPETITE (loss of appetite), ASTHENIA (weakness), DIZZINESS (dizziness), MYALGIA (the whole body was aching so bad that wanted to cry), HEADACHE (severe head ache), NAUSEA (nausea) and PYREXIA (woke up with slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased heart beats per minute (High) Heart rate increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient scheduled for second Moderna vaccine on 2-19-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner.  No Treatment medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 19-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021). On 19-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient scheduled for second Moderna vaccine on 2-19-2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner.  No Treatment medication was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) and FATIGUE (Tiredness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder cancer, Kidney cancer and Prostate cancer.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore arm) and FATIGUE (Tiredness). At the time of the report, INJECTION SITE PAIN (Sore arm) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication nor treatment information provided.  Patient has difficulty in getting for dose 2 vaccine, earliest date are given after 45 days of 1st vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitant medication nor treatment provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 CHILLS (chills). At the time of the report, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication nor teeatment information provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Headache, Influenza like illness, Injection site discolouration
Clinical narrative: warm arm; pink arm; swollen arm; injection site itching; "flu like" illness; flushing; headache; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm), INFLUENZA LIKE ILLNESS ("flu like" illness) and FLUSHING (flushing) in a 67-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.     The patient's past medical history included Rheumatoid arthritis and Osteoarthritis. Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PARACETAMOL (TYLENOL), HYDROCORTISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), POLYCARBOPHIL CALCIUM (FIBER), TOFACITINIB CITRATE (XELJANZ), PANTOPRAZOLE, OMEPRAZOLE, FOLIC ACID, METOPROLOL, MONTELUKAST SODIUM (SINGULAIR), ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN & MINERAL, PROBIOTIC 10, UBIDECARENONE (COQ) and TRAMADOL for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE DISCOLOURATION (pink arm). On 08-Mar-2021, the patient experienced FEELING HOT (warm arm). The patient was treated with HYDROCORTISONE (HYDROCORTISONE CREAM) for Injection site redness, Injection site itching and Swelling, at an unspecified dose and frequency. On 03-Mar-2021, INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown.            Patient concomitant medicines include nasal saline spray but unknown as well  taken cool compress treatment to relieve the symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Peripheral swelling, Vaccination site erythema
Clinical narrative: warm arm; pink arm; swollen arm; injection site itching; "flu like" illness; flushing; headache; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm), INFLUENZA LIKE ILLNESS ("flu like" illness) and FLUSHING (flushing) in a 67-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.     The patient's past medical history included Rheumatoid arthritis and Osteoarthritis. Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PARACETAMOL (TYLENOL), HYDROCORTISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), POLYCARBOPHIL CALCIUM (FIBER), TOFACITINIB CITRATE (XELJANZ), PANTOPRAZOLE, OMEPRAZOLE, FOLIC ACID, METOPROLOL, MONTELUKAST SODIUM (SINGULAIR), ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN & MINERAL, PROBIOTIC 10, UBIDECARENONE (COQ) and TRAMADOL for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE DISCOLOURATION (pink arm). On 08-Mar-2021, the patient experienced FEELING HOT (warm arm). The patient was treated with HYDROCORTISONE (HYDROCORTISONE CREAM) for Injection site redness, Injection site itching and Swelling, at an unspecified dose and frequency. On 03-Mar-2021, INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown.            Patient concomitant medicines include nasal saline spray but unknown as well  taken cool compress treatment to relieve the symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash
Clinical narrative: Headache; fatigue; rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (fatigue) and INJECTION SITE RASH (rash on injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included cholestrol since an unknown date. Concurrent medical conditions included Diabetes and Hypertension.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash on injection site). On 04-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Fatigue and Injection site rash, at an unspecified dose and frequency. On 04-Mar-2021, INJECTION SITE RASH (rash on injection site) had resolved. On 07-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking medications for Cholesterol, diabetic and high blood pressure.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Neck pain, Pain in extremity
Clinical narrative: Sore biceps; Achy neck; Warm to the touch at the site of injection; achy shoulders; redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0111A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection). The patient was treated with PARACETAMOL (TYNELOL) for Injection site erythema, Neck pain, Arthralgia, sore biceps and Pain in extremity, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore biceps), NECK PAIN (Achy neck), INJECTION SITE WARMTH (Warm to the touch at the site of injection), ARTHRALGIA (achy shoulders) and INJECTION SITE ERYTHEMA (redness at the site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: blotchy spots on both of my arms; my arms look a little puffy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Edema since an unknown date and Surgery (Cataract Surgery 2 days ago).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy). At the time of the report, RASH (blotchy spots on both of my arms) and PERIPHERAL SWELLING (my arms look a little puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: extremely heavy period/She is now filling adult diapers with blood; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 1:00 PM, the patient experienced HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood). At the time of the report, HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood) 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 and treatment information were not reported.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Urinary tract infection
Clinical narrative: Stomach Discomfort.; UTI Symptoms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026AZ1A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included LEVOTHYROXINE, LOSARTAN and ATORVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills). The patient was treated with VACCINIUM MACROCARPON FRUIT (CRANBERRY JUICE [VACCINIUM MACROCARPON FRUIT]) for Stomach discomfort, UTI and Chills, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach Discomfort.), URINARY TRACT INFECTION (UTI Symptoms) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: swollen hand; itching in her hand; big red spot; hot; burning; getting bigger and more red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot) and BURNING SENSATION (burning) in a 40-year-old patient of an unknown gender 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 provided.  Concomitant products included ZINC for Supplementation therapy, ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for Vitamin supplementation.    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 PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red). At the time of the report, PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that she read on CDC website, where 14 people were reported with same reactions   Received vaccine at her home.  No treatment information provided.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: swollen hand; itching in her hand; big red spot; hot; burning; getting bigger and more red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot) and BURNING SENSATION (burning) in a 40-year-old patient of an unknown gender 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 provided.  Concomitant products included ZINC for Supplementation therapy, ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for Vitamin supplementation.    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 PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red). At the time of the report, PERIPHERAL SWELLING (swollen hand), PRURITUS (itching in her hand), RASH MACULAR (big red spot), FEELING HOT (hot), BURNING SENSATION (burning) and ERYTHEMA (getting bigger and more red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that she read on CDC website, where 14 people were reported with same reactions   Received vaccine at her home.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: aching body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aching body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included OXYCODONE, GABAPENTIN and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (aching body). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (aching body) 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.   Patient has taken vaccine at the Health Department.   This case was linked to MOD-2021-037486 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site rash, Vaccination site reaction
Clinical narrative: Covid arm; expanded rash to underside of arm and up to elbow; rash at injection site; feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), PYREXIA (feverish), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Acid reflux (esophageal).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (feverish). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE RASH (rash at injection site) and RASH (expanded rash to underside of arm and up to elbow) outcome was unknown and PYREXIA (feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication, triglyceride medication and potassium. The patient felt feverish eight days after the first dose and that lasted for 2-2.5 days. It was reported that the rash had begun to lighten up.