chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Body rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), POTASSIUM CHLORIDE, LISINOPRIL, LATANOPROST, CLONAZEPAM, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), OMEPRAZOLE, LEVOTHYROXINE, VITAMIN D NOS, CALCIUM, ZINC and LORATADINE (CLARITINE) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and RASH (Body rash). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Medications: advair diskus 250/50, albuterol inhaler, Claritin, Vitamin C, Flonase.   This case was linked to MOD-2021-035612 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose scheduled for 44 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose scheduled for 44 days after first dose) had resolved.            No treatment and concomitant medications were provided.   This case was linked to MOD-2021-035594 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273, (Lot number: Unknown), with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: not feeling well overall; nausea; redness at injection site; widespread pain throughout entire body; Left arm pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall), NAUSEA (nausea) and INJECTION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN) and CELECOXIB (CELEBREX) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain) and INJECTION SITE ERYTHEMA (redness at injection site). On 05-Mar-2021, the patient experienced MALAISE (not feeling well overall) and NAUSEA (nausea). At the time of the report, PAIN (widespread pain throughout entire body), PAIN IN EXTREMITY (Left arm pain), MALAISE (not feeling well overall) and NAUSEA (nausea) outcome was unknown and INJECTION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received treatment for the events - muscle relaxer, Bayer and Diclofenac potassium 50 mg tablets.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Pain
Clinical narrative: BLOODY NOSE; BODY ACHE; HEADACHE; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (BLOODY NOSE), PAIN (BODY ACHE) and HEADACHE (HEADACHE) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (BODY ACHE) and HEADACHE (HEADACHE). On 05-Mar-2021, the patient experienced EPISTAXIS (BLOODY NOSE). At the time of the report, EPISTAXIS (BLOODY NOSE), PAIN (BODY ACHE) and HEADACHE (HEADACHE) outcome was unknown.            Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation, Hypoaesthesia
Clinical narrative: (numbness) in hand (numbness) in hand/ facial (numbness)/ a little bit of numbness in right hip; I started with mild symptoms and then they got progressively worse; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (I started with mild symptoms and then they got progressively worse) and HYPOAESTHESIA ((numbness) in hand (numbness) in hand/ facial (numbness)/ a little bit of numbness in right hip) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (I started with mild symptoms and then they got progressively worse) and HYPOAESTHESIA ((numbness) in hand (numbness) in hand/ facial (numbness)/ a little bit of numbness in right hip). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (I started with mild symptoms and then they got progressively worse) and HYPOAESTHESIA ((numbness) in hand (numbness) in hand/ facial (numbness)/ a little bit of numbness in right hip) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Myalgia
Clinical narrative: sore arm; itchy eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy eye) and MYALGIA (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    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 EYE PRURITUS (itchy eye). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, EYE PRURITUS (itchy eye) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Pain; chills; headaches; fever; cough; aches; This spontaneous case was reported by a physician and describes the occurrence of COUGH (cough), PAIN (aches), PAIN (Pain), PYREXIA (fever) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METFORMIN, METOPROLOL and ATORVASTATIN for an unknown indication.    On 03-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 COUGH (cough), PAIN (aches) and PYREXIA (fever). On 04-Mar-2021, the patient experienced PAIN (Pain), CHILLS (chills) and HEADACHE (headaches). At the time of the report, COUGH (cough), PAIN (aches), PAIN (Pain), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) 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 treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: started to feel freezing or chills; Mild fatigue; low-grade temperature 99-100; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Colon polyps, Diverticulitis intestinal perforated, Prostatism in 2008 and Stent placement since 09-Jun-2008. Concurrent medical conditions included Obstructive sleep apnea syndrome since 25-Oct-2018, Essential hypertension since 26-Mar-2021, GERD since 26-Mar-2018, Cystic kidney disease since 26-Mar-2018, Atrial fibrillation since 31-Jan-2017, Erectile dysfunction NOS since 26-Mar-2018, Constipation chronic since 26-Mar-2021, Coronary artery disease since 31-Jan-2017, Allergic rhinitis, Drug allergy (allergy to atorvastatin), Drug allergy (allergy to baclofen), Allergic reaction to antibiotics (allergic to Ciprofloxacin HCl), Allergic reaction to antibiotics (Levaquin (levofloxacin)), Allergic reaction to antibiotics (allergic to sulfamethoxazole), Allergic reaction to antibiotics (allergic to Trimethoprim) and Sulfonamide allergy. Concomitant products included DIAZEPAM from 14-Jan-2021 to an unknown date for Anxiety, METHYLCELLULOSE (CITRUCEL) for Laxative supportive care, APIXABAN, ACETYLSALICYLIC ACID (ASPIRIN E.C), DEXLANSOPRAZOLE from 28-Dec-2017 to an unknown date, FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL], HYDRALAZINE from 27-Jun-2017 to an unknown date, LISINOPRIL, LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST from 02-Jul-2020 to an unknown date, MULTIVITAMIN [VITAMINS NOS], NIZATIDINE (AXID AR) from 07-Nov-2019 to an unknown date, ROSUVASTATIN CALCIUM (CRESTOR) and TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100). At the time of the report, CHILLS (started to feel freezing or chills), FATIGUE (Mild fatigue) and PYREXIA (low-grade temperature 99-100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.1 (High) 99.1. On 05-Mar-2021, Body temperature: 100 (High) 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Medical history added. Dose 2 details added. Concomitant medications added. Events added.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient reports sore left arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient reports sore left arm after receiving 1st dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2019) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Patient reports sore left arm after receiving 1st dose). At the time of the report, PAIN IN EXTREMITY (Patient reports sore left arm after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: NNI
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspepsia, Nausea
Clinical narrative: heartburn; didnt want to eat; nauseated/thought he might vomit; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit). At the time of the report, DYSPEPSIA (heartburn), DECREASED APPETITE (didnt want to eat) and NAUSEA (nauseated/thought he might vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; nausea; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (nausea) and CHILLS ( chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included BISOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PANTOPRAZOLE and VITAMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea) and CHILLS ( chills). At the time of the report, NAUSEA (nausea) 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.   Treatment information was not provided.   This case was linked to MOD-2021-076024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: Added concomitant medications
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Lump at the injection the side; Sore at the injection the side; Red at the injection the side; Swelling at the injection the side; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE MASS (Lump at the injection the side), VACCINATION SITE PAIN (Sore at the injection the side), VACCINATION SITE ERYTHEMA (Red at the injection the side), VACCINATION SITE SWELLING (Swelling at the injection the side) and PYREXIA (Slight fever) outcome was unknown.            No concomitant medications reported by reporter.  Treatment medication not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Neck pain
Clinical narrative: Pain around the breast; Pain around her neck; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and NAPROXEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 06-Feb-2021, BREAST PAIN (Pain around the breast) and NECK PAIN (Pain around her neck) had resolved.            Concomitant product use was not provided by the reporter.    Patient took second shot of vaccine and 15 days later she had pain around the breast and neck.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Swollen arm; Arm itchy; Moderna Arm - Itchiness; Moderna Arm - Red Spot; Moderna arm - Swollen; Moderna arm - hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen), VACCINATION SITE WARMTH (Moderna arm - hot) and PERIPHERAL SWELLING (Swollen arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Drug allergy, Dairy intolerance, Food allergy (Wheat, shell fish), Adhesive tape allergy (Band aid), Allergy (Allergic to own body yeast) since 1987 and Vaso vagal attack (Vaso Vagal Syndrome). Concomitant products included LEVOTHYROXINE, METFORMIN, SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS, LACTOBACILLUS), OMEPRAZOLE, FLUCONAZOLE (DIFLUCAN), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIFLEX SOFT CHEWS), MAGNESIUM, COLECALCIFEROL, UBIDECARENONE (COQ10+D), VITAMIN D NOS, VITAMIN E NOS, VITAMIN B NOS, CAPRYLIC ACID and COLLAGEN for an unknown indication, ASCORBIC ACID (VITAMIN C CITRUS).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy). On 09-Mar-2021, VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (nose swab test).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included Cortisone   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: Received VAERS form  included patients minor details, allergies  and current condition ,SAE stop date second dose details concomitant medications and two new events  was added
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen arm; Arm itchy; Moderna Arm - Itchiness; Moderna Arm - Red Spot; Moderna arm - Swollen; Moderna arm - hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen), VACCINATION SITE WARMTH (Moderna arm - hot) and PERIPHERAL SWELLING (Swollen arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Nov-2020. Concurrent medical conditions included Drug allergy, Dairy intolerance, Food allergy (Wheat, shell fish), Adhesive tape allergy (Band aid), Allergy (Allergic to own body yeast) since 1987 and Vaso vagal attack (Vaso Vagal Syndrome). Concomitant products included LEVOTHYROXINE, METFORMIN, SIMVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS, LACTOBACILLUS), OMEPRAZOLE, FLUCONAZOLE (DIFLUCAN), CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIFLEX SOFT CHEWS), MAGNESIUM, COLECALCIFEROL, UBIDECARENONE (COQ10+D), VITAMIN D NOS, VITAMIN E NOS, VITAMIN B NOS, CAPRYLIC ACID and COLLAGEN for an unknown indication, ASCORBIC ACID (VITAMIN C CITRUS).   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy). On 09-Mar-2021, VACCINATION SITE PRURITUS (Moderna Arm - Itchiness), VACCINATION SITE ERYTHEMA (Moderna Arm - Red Spot), VACCINATION SITE SWELLING (Moderna arm - Swollen) and VACCINATION SITE WARMTH (Moderna arm - hot) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Arm itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (nose swab test).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment included Cortisone   Most recent FOLLOW-UP information incorporated above includes: On 05-Mar-2021: Received VAERS form  included patients minor details, allergies  and current condition ,SAE stop date second dose details concomitant medications and two new events  was added
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Feeling tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 22321) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 19-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 DIZZINESS (Dizziness) and FATIGUE (Feeling tired). At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID after Ist dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine). At the time of the report, COVID-19 (Had COVID after Ist dose of the Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Injection site pain
Clinical narrative: stomache cramp; diarhea; ache at injection sight; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight). At the time of the report, ABDOMINAL PAIN UPPER (stomache cramp), DIARRHOEA (diarhea) and INJECTION SITE PAIN (ache at injection sight) 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.   Treatment information include : drank 7up and took an antacid. No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Erythema, Pain
Clinical narrative: red about a size of a nickle; achiness; sore left arm; 12 to 14 hours, she started with fever(101); After 12 to 14 hours, chills and achiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, FAMOTIDINE and LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Feb-2021, the patient experienced ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Body temperature: 101 (High) high fever. On 04-Nov-2020, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: red about a size of a nickle; achiness; sore left arm; 12 to 14 hours, she started with fever(101); After 12 to 14 hours, chills and achiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Nov-2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, FAMOTIDINE and LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Feb-2021, the patient experienced ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (red about a size of a nickle), PAIN (achiness), PAIN IN EXTREMITY (sore left arm), PYREXIA (12 to 14 hours, she started with fever(101)) and CHILLS (After 12 to 14 hours, chills and achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Body temperature: 101 (High) high fever. On 04-Nov-2020, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Muscular weakness, Vomiting
Clinical narrative: weakness in legs; Hip pain cannot walk; Hip pain cannot walk; chill; vomit; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs), ARTHRALGIA (Hip pain cannot walk), GAIT DISTURBANCE (Hip pain cannot walk), CHILLS (chill) and VOMITING (vomit) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MZ0A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs), ARTHRALGIA (Hip pain cannot walk), GAIT DISTURBANCE (Hip pain cannot walk), CHILLS (chill) and VOMITING (vomit). At the time of the report, MUSCULAR WEAKNESS (weakness in legs), ARTHRALGIA (Hip pain cannot walk), GAIT DISTURBANCE (Hip pain cannot walk), CHILLS (chill) and VOMITING (vomit) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included Tylenol 3 doses 4March2021, No HCP Consulted.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received and contains no new information.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: third injection administered; A spontaneous report was received from a healthcare professional  concerning a 96-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  third injection administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 9-Feb-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4-Mar-2021, the patient accidently received third injection .Treatment details was not reported.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The outcome of event , third injection administered, was considered resolved.; Reporter's Comments: This report refers to a 96-years-old female patient who was administered a third injection administered (Extra dose administered) for mRNA-1273 (Lot# unknown). There were no reported AEs associated with this case of extra dose administered
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Vaccination site erythema
Clinical narrative: Red dots similar to chickenpox; Redness on her arm around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and MULTIVITAMIN & MINERAL for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAPULE (Red dots similar to chickenpox) and VACCINATION SITE ERYTHEMA (Redness on her arm around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 05-Mar-2021 morning, the site was more red probably 2 inches in diameter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria; Generalised Itching/pruritus; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus) in an 81-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 Breast cancer in 2009 and GERD. Concurrent medical conditions included Hives, Blood cholesterol, Heart disorder, Blood pressure high, AFib, Anxiety, Diabetes and Drug allergy (Allopurinol). Concomitant products included LOSARTAN POTASSIUM, FLECAINIDE ACETATE, FAMOTIDINE, FUROSEMIDE, APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM, DILTIAZEM (CARDIZEM [DILTIAZEM]), PRAMIPEXOLE DIHYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE (CARDIZEM CD) from 06-Aug-2020 to an unknown date, ROSUVASTATIN CALCIUM (CRESTOR), POTASSIUM CHLORIDE and VITAMIN D3 for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 04-Mar-2021 at an unspecified dose and frequency. On 27-Apr-2021, URTICARIA (Hive all over her body/generalised pruritic urticaria and continued to have intermittent urticaria) and PRURITUS (Generalised Itching/pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported developing generalized pruritic urticaria 4 hours after the administration of dose 1 . She continued to have intermittent urticaria for the next 4 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received on 30-JUL-2021 contains significant information. The primary reporter details added. The patient demographics were added. The patient medical history were added. The concomitant and treatment medication were added. The start date of suspect drug was updated. The new event was added. The event outcome was updated from unknown to recovered/resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Sore arm; Arm is swollen; Itching; Arm is red; Arm is very hard; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red), VACCINATION SITE INDURATION (Arm is very hard) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna COVID-19 vaccine and experienced a sore arm and itching right after the vaccine and the next day. On 05-Mar-2021, the patient experienced chills all day long and noticed in the evening that their arm was swollen, was very hard and red.  Treatment medication also included Allergy Relief.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Sore arm; Arm is swollen; Itching; Arm is red; Arm is very hard; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D NOS and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red) and VACCINATION SITE INDURATION (Arm is very hard). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Arm is swollen), PRURITUS (Itching), ERYTHEMA (Arm is red), VACCINATION SITE INDURATION (Arm is very hard) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna COVID-19 vaccine and experienced a sore arm and itching right after the vaccine and the next day. On 05-Mar-2021, the patient experienced chills all day long and noticed in the evening that their arm was swollen, was very hard and red.  Treatment medication also included Allergy Relief.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site urticaria
Clinical narrative: very itchy; hives, in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm) in a 73-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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm). On 04-Mar-2021, PRURITUS (very itchy) and VACCINATION SITE URTICARIA (hives, in the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information included, Topical histamine was provided.    This case was linked to MOD-2021-036056 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: Pink mark on the same site of the injection; Soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink mark on the same site of the injection) and VACCINATION SITE PAIN (Soreness on his arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 VACCINATION SITE PAIN (Soreness on his arm). On 04-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink mark on the same site of the injection). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink mark on the same site of the injection) and VACCINATION SITE PAIN (Soreness on his arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Insomnia, Pyrexia
Clinical narrative: diarrhea; cannot sleep; really bad headache; chills; running a "slow-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever). At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.