chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it), FORMICATION (It's almost like skin crawling), BURNING SENSATION (Razor burn with a chill on top), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it), FORMICATION (It's almost like skin crawling), BURNING SENSATION (Razor burn with a chill on top), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (A hot sensation on the skin with a cold sensation on top of it) had not resolved, FORMICATION (It's almost like skin crawling) and BURNING SENSATION (Razor burn with a chill on top) outcome was unknown and PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive in Decemebr-2020..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pruritus, Vaccination site rash
Clinical narrative: It itches a little bit in one spot; Rash on the upper arm of the injection site; Extra dose administerd; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 016M20A and 038B2114) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd). At the time of the report, VACCINATION SITE PRURITUS (It itches a little bit in one spot), VACCINATION SITE RASH (Rash on the upper arm of the injection site) and EXTRA DOSE ADMINISTERED (Extra dose administerd) outcome was unknown.            No concomitants and Treatment medications were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore on arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore on arm) and FATIGUE (Felt tired) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore on arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore on arm) and FATIGUE (Felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were provided.  No treatment medication were provided.   This case was linked to MOD-2021-293438, MOD-2021-294665 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Vaccination site pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  The patient did not had any problems after first two doses.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Fatigue, Pyrexia, Vertigo
Clinical narrative: Worsening of vertigo; Body exacerbated; High temperature; Arms and legs fatigue immediately; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Multiple sclerosis relapse (Relapsing remitting multiple sclerosis), Vertigo, Vitamin D low, Migraine, Inflammatory bowel disease (IBS), Trouble falling asleep (Trouble sleeping), Depression, Anxiety, Polycystic ovarian syndrome, B12 deficiency anemia, Insulin resistance (Insulin resistance associated with PCOS), Drug allergy (Vicodin), Drug allergy (Percocet), Drug allergy (Dilaudid), Latex allergy, Drug allergy (Wellbutrin allergy), Drug allergy (Celexa allergy), Drug allergy (Tecfidera allergy), Drug allergy and Pain. Concomitant products included OCRELIZUMAB (OCREVUS), CLONAZEPAM, VITAMIN D2, TOPIRAMATE, GABAPENTIN, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), DICYCLOMINE [DICYCLOVERINE], TRAZODONE, PAROXETINE, NORETHISTERONE (DEBLITANE), CYANOCOBALAMIN, METFORMIN, LORAZEPAM, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 21-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately). At the time of the report, VERTIGO (Worsening of vertigo), CONDITION AGGRAVATED (Body exacerbated), PYREXIA (High temperature) and FATIGUE (Arms and legs fatigue immediately) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant medications also included steroids.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Burning sensation in my right foot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in my right foot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning sensation in my right foot). At the time of the report, BURNING SENSATION (Burning sensation in my right foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling) 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 05-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling). At the time of the report, MYALGIA (Body/muscle aches) and PYREXIA (Feverish feeling) had not resolved.            No concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Skin warm, Swelling
Clinical narrative: shoulder warm; shoulder swollen; she was seeing swelling under her arm; Shoulder sore; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore). At the time of the report, SKIN WARM (shoulder warm), SWELLING (shoulder swollen), LYMPHADENOPATHY (she was seeing swelling under her arm) and ARTHRALGIA (Shoulder sore) outcome was unknown.            Patient was taking steroids. No treatment information was provided.   This case was linked to MOD-2021-293902 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Reaction on my skin from the shot; 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 SKIN REACTION (Reaction on my skin from the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (Reaction on my skin from the shot). At the time of the report, SKIN REACTION (Reaction on my skin from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided  No Treatment Medications were provided.   Reporter did not allow further contact
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) and VOMITING (Vomiting) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concomitant products included ALECTINIB HYDROCHLORIDE (ALECENSA) for an unknown indication.    On 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIARRHEA (Diarrhea) and VOMITING (Vomiting). At the time of the report, DIARRHEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Disorientation, Dizziness, Influenza like illness, Lethargy
Clinical narrative: Sleepy; neck pain; flu like symptoms; Coughing; green phlegm; lethargy; dizziness; disorientation; After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out; freezing cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing) and SPUTUM DISCOLOURED (green phlegm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045821A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), MESALAZINE (LIALDA), PREDNISONE, AZATHIOPRINE, CHOLESTYRAMINE, TAMSULOSIN, ALPRAZOLAM, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever) was resolving. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Nasopharyngitis, Neck pain, Pyrexia, Somnolence
Clinical narrative: Sleepy; neck pain; flu like symptoms; Coughing; green phlegm; lethargy; dizziness; disorientation; After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out; freezing cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing) and SPUTUM DISCOLOURED (green phlegm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045821A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), MESALAZINE (LIALDA), PREDNISONE, AZATHIOPRINE, CHOLESTYRAMINE, TAMSULOSIN, ALPRAZOLAM, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever) was resolving. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured
Clinical narrative: Sleepy; neck pain; flu like symptoms; Coughing; green phlegm; lethargy; dizziness; disorientation; After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out; freezing cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing) and SPUTUM DISCOLOURED (green phlegm) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 045821A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), MESALAZINE (LIALDA), PREDNISONE, AZATHIOPRINE, CHOLESTYRAMINE, TAMSULOSIN, ALPRAZOLAM, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), NECK PAIN (neck pain), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Coughing), SPUTUM DISCOLOURED (green phlegm), LETHARGY (lethargy), DIZZINESS (dizziness), DISORIENTATION (disorientation), LIMB DISCOMFORT (After getting this shot in my arm my arm felt like it was going to fall off like a hole was scooped out), NASOPHARYNGITIS (freezing cold) and PYREXIA (Fever) was resolving. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and HEADACHE (Headaches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced FATIGUE (fatigued). On 23-Aug-2021, the patient experienced HEADACHE (Headaches). At the time of the report, FATIGUE (fatigued) was resolving and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Did not feel well; Had a fever that evening; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well) and PYREXIA (Had a fever that evening) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Overweight. Concomitant products included LISINOPRIL for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (Did not feel well) and PYREXIA (Had a fever that evening). On 02-Mar-2021, MALAISE (Did not feel well) and PYREXIA (Had a fever that evening) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-294162 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient didn't get the second in 4 weeks and is 6 months past the first) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient didn't get the second in 4 weeks and is 6 months past the first). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient didn't get the second in 4 weeks and is 6 months past the first) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not  provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hyperhidrosis, Illness, Product dose omission issue
Clinical narrative: Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet; Sick; Were so cold/could not get warm; They were shaking so hard/ shook for hours/hard shakes; Broke into a sweat; Shivering very hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder (thyroid condition), Migraine and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, TOPIRAMATE for Migraine, LEVOTHYROXINE for Thyroid disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet). At the time of the report, ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Night around 3am started shivering Patient stated she didn't took her regular medicines on that day No treatment information was reported by reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet; Sick; Were so cold/could not get warm; They were shaking so hard/ shook for hours/hard shakes; Broke into a sweat; Shivering very hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder (thyroid condition), Migraine and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, TOPIRAMATE for Migraine, LEVOTHYROXINE for Thyroid disorder.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet). At the time of the report, ILLNESS (Sick), FEELING COLD (Were so cold/could not get warm), TREMOR (They were shaking so hard/ shook for hours/hard shakes), HYPERHIDROSIS (Broke into a sweat) and CHILLS (Shivering very hard) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 20Apr2021 on the left arm and has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Night around 3am started shivering Patient stated she didn't took her regular medicines on that day No treatment information was reported by reporter
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021). At the time of the report, COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and HEADACHE (headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 035B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, 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 experienced MYALGIA (sore arm) and HEADACHE (headache). At the time of the report, MYALGIA (sore arm) and HEADACHE (headache) had resolved.            concomitant and treatment drugs were not provided
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Vaccine exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M2019 and 028L20AL1) for COVID-19 vaccination.     The patient's past medical history included Miscarriage on 09-Nov-2020. Concurrent medical conditions included Nicotine abuse on 29-Jul-2002.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Jul-2021 and the estimated date of delivery was 13-Mar-2022. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Vaccine exposure before pregnancy) outcome was unknown. Not Provided          No adverse events reported.  Concomitant medications were not provided.  Treatment medication was not provided.  Date of positive pregnancy test was 08 Aug 2021  Estimated date of conception was 18 Jul 2021  No Maternal history of subfertility and complications or acute illnesses during pregnancy to date.  Number of fetuses were unknown  Number of previous pregnancies were two. On 05 Sep 2012 patient gave live full term birth and on 09 Nov 2020 patient had a miscarriage at 13 weeks genetic issues as per labs.  No Family history of congenital anomalies/genetic diseases   Patient have the current history of substance use on Nicotine 1 pack per day, since 29-Jul- 2002.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Additional information received on 25 Aug 2021 contains significant information. Reporter  details updated. Patient details updated. Product details updated. Event onset date updated.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a mild/moderate reaction to the vaccine with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses). At the time of the report, VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-294075 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Productive cough
Clinical narrative: Accumulation of mucus; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough). At the time of the report, PRODUCTIVE COUGH (Accumulation of mucus) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported.  It was reported that patient had similar symptoms of accumulation of mucus and cough after receiving the Moderna vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Headache, Polymerase chain reaction
Clinical narrative: She still doesn't feel like her self; Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5); 102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F; Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (She still doesn't feel like her self), FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR OD) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone). On an unknown date, the patient experienced FEELING ABNORMAL (She still doesn't feel like her self). At the time of the report, FEELING ABNORMAL (She still doesn't feel like her self) outcome was unknown and FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Body temperature: 99.4 (High) 99.4 F. On an unknown date, Body temperature: 102.6 f (High) 102.6 F temperature. On an unknown date, Polymerase chain reaction: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported.   This case was linked to MOD-2021-294235 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She still doesn't feel like her self; Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5); 102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F; Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (She still doesn't feel like her self), FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR OD) for an unknown indication.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone). On an unknown date, the patient experienced FEELING ABNORMAL (She still doesn't feel like her self). At the time of the report, FEELING ABNORMAL (She still doesn't feel like her self) outcome was unknown and FATIGUE (Extreme fatigue (described as 5 out of 5)/ the fatigue is not as bad as before (described as 3 out of 5)), PYREXIA (102.6 F temperature/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F) and HEADACHE (Headache/ Now (23Aug2021), she has a tiny bit of fever, 99.4 F, the headache is pretty much gone) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Body temperature: 99.4 (High) 99.4 F. On an unknown date, Body temperature: 102.6 f (High) 102.6 F temperature. On an unknown date, Polymerase chain reaction: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported.   This case was linked to MOD-2021-294235 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sorer arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYALGIA (sorer arm). At the time of the report, MYALGIA (sorer arm) outcome was unknown.            Concomitant medication includes chemotherapy pill.   Treatment information was not provided.   This case was linked to MOD-2021-294214, MOD-2021-294231 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Chills; Fever; Tiredness; Achiness; Sore arm; Her arm became swollen, red at injection site, and very itchy; Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm; Her arm became swollen, red at injection site, and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 027L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm) and VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy). On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness) and MYALGIA (Achiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm), VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy) and MYALGIA (Achiness) outcome was unknown.            Concomitant medication include daily chemotherapy pill.  Treatment also include lots of ice.  Patient had the symptoms 24 hours after the third dose and she was in bed for 48 hours and now reporter says that it was going away at the time of reporting.   This case was linked to MOD-2021-294214, MOD-2021-294229 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Chills; Fever; Tiredness; Achiness; Sore arm; Her arm became swollen, red at injection site, and very itchy; Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm; Her arm became swollen, red at injection site, and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 027L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm) and VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy). On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness) and MYALGIA (Achiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm), VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy) and MYALGIA (Achiness) outcome was unknown.            Concomitant medication include daily chemotherapy pill.  Treatment also include lots of ice.  Patient had the symptoms 24 hours after the third dose and she was in bed for 48 hours and now reporter says that it was going away at the time of reporting.   This case was linked to MOD-2021-294214, MOD-2021-294229 (Patient Link).