chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Feeling abnormal, Gait inability, Limb discomfort, Myalgia
Clinical narrative: feels very rocky legs like rubbery legs; felt blocky; ache all over; hand was shaking while eating; felt so cold; Lost bowel control; Lost bladder control; fell on the floor 5x/fell on the bathroom/she fell on the chair; Bruises on outside the leg / Bruises on outside knee; sore left clavicle; broke 2 tooth; felt really scared; cannot neither crawl nor walk; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair) and CONTUSION (Bruises on outside the leg / Bruises on outside knee) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clavicle fracture (Patient's left clavicle was sore when she fell but mentioned it could be because she had broke it a month ago.). Concurrent medical conditions included Drug allergy (Allergic to Biaxin.), Drug allergy (Allergic to Macrodantin.), Allergy to antibiotic (Allergic to Azithromycin.), Allergy to antibiotic (Allergic to Vantin.) and Drug allergy (Allergic to Travatan eye drops.). Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared) and GAIT INABILITY (cannot neither crawl nor walk). On 01-Sep-2021, the patient experienced TREMOR (hand was shaking while eating). On 04-Sep-2021, the patient experienced LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared), GAIT INABILITY (cannot neither crawl nor walk), TREMOR (hand was shaking while eating), LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Tooth injury, Tremor
Clinical narrative: feels very rocky legs like rubbery legs; felt blocky; ache all over; hand was shaking while eating; felt so cold; Lost bowel control; Lost bladder control; fell on the floor 5x/fell on the bathroom/she fell on the chair; Bruises on outside the leg / Bruises on outside knee; sore left clavicle; broke 2 tooth; felt really scared; cannot neither crawl nor walk; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair) and CONTUSION (Bruises on outside the leg / Bruises on outside knee) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clavicle fracture (Patient's left clavicle was sore when she fell but mentioned it could be because she had broke it a month ago.). Concurrent medical conditions included Drug allergy (Allergic to Biaxin.), Drug allergy (Allergic to Macrodantin.), Allergy to antibiotic (Allergic to Azithromycin.), Allergy to antibiotic (Allergic to Vantin.) and Drug allergy (Allergic to Travatan eye drops.). Concomitant products included GABAPENTIN, TIZANIDINE HCL and EZETIMIBE for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared) and GAIT INABILITY (cannot neither crawl nor walk). On 01-Sep-2021, the patient experienced TREMOR (hand was shaking while eating). On 04-Sep-2021, the patient experienced LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (felt so cold), ANAL INCONTINENCE (Lost bowel control), BLADDER DISORDER (Lost bladder control), FALL (fell on the floor 5x/fell on the bathroom/she fell on the chair), CONTUSION (Bruises on outside the leg / Bruises on outside knee), BONE PAIN (sore left clavicle), TOOTH INJURY (broke 2 tooth), FEAR (felt really scared), GAIT INABILITY (cannot neither crawl nor walk), TREMOR (hand was shaking while eating), LIMB DISCOMFORT (feels very rocky legs like rubbery legs), FEELING ABNORMAL (felt blocky) and MYALGIA (ache all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: flu like symptom; shortness of breath (diagnosed with lung damage early 2019); fatigue; headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Lung disorder since 2019, Allergy, Diabetes and Blood cholesterol abnormal.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medication reported were unspecified diabetic medication, blood thinner and cholesterol medication.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: flu like symptom; shortness of breath (diagnosed with lung damage early 2019); fatigue; headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Lung disorder since 2019, Allergy, Diabetes and Blood cholesterol abnormal.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom), DYSPNOEA (shortness of breath (diagnosed with lung damage early 2019)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medication reported were unspecified diabetic medication, blood thinner and cholesterol medication.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: i would like to report side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i would like to report side effects) 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 would like to report side effects). At the time of the report, VACCINATION COMPLICATION (i would like to report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Upper stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Upper stomach pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced ABDOMINAL PAIN UPPER (Upper stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Upper stomach pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.   This case was linked to MOD-2021-307921 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Dyspnoea, Electrocardiogram, Oxygen saturation
Clinical narrative: Report side effects; Breathing problem; Asthma problems; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effects), DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 010M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Hypothyroidism and Asthma. Concomitant products included VITAMIN D3, THYROID (ARMOUR THYROID), SERTRALINE, ATOMOXETINE and OMEPRAZOLE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-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 DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report side effects). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Report side effects) outcome was unknown and DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Oxygen saturation: 97-98 (normal) normal.         Treatment medication include butanol Inhaler.   This case was linked to MOD-2021-313599 (Parent-Child Link). This case was linked to MOD-2021-313591 (Patient Link).   See case MOD-2021-313599 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021 and contains no new information On 08-Sep-2021: Follow up received on 08-SEP-2021 Reporter information updated, patient demographics updated, medical history updated, lab data updated, concomitant medication updated, treatment medication updated, events updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report side effects; Breathing problem; Asthma problems; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effects), DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 010M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease, Hypothyroidism and Asthma. Concomitant products included VITAMIN D3, THYROID (ARMOUR THYROID), SERTRALINE, ATOMOXETINE and OMEPRAZOLE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-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 DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report side effects). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Report side effects) outcome was unknown and DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Oxygen saturation: 97-98 (normal) normal.         Treatment medication include butanol Inhaler.   This case was linked to MOD-2021-313599 (Parent-Child Link). This case was linked to MOD-2021-313591 (Patient Link).   See case MOD-2021-313599 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021 and contains no new information On 08-Sep-2021: Follow up received on 08-SEP-2021 Reporter information updated, patient demographics updated, medical history updated, lab data updated, concomitant medication updated, treatment medication updated, events updated.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Minor sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Minor sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (Minor sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, MYALGIA (Minor sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.  This case was linked to MOD-2021-308020, MOD-2021-308039 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: she had a minor sore arm the next day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had a minor sore arm the next day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced MYALGIA (she had a minor sore arm the next day). At the time of the report, MYALGIA (she had a minor sore arm the next day) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported. Patient reported that she probably received her first shot in her right arm.   This case was linked to MOD-2021-308014, MOD-2021-308023 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever/Fever; Vomiting; Intense diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever/Fever), VOMITING (Vomiting) and DIARRHOEA (Intense diarrhea) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PYREXIA (Fever/Fever) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization) and DIARRHOEA (Intense diarrhea) (seriousness criterion hospitalization). The patient was hospitalized until 04-Sep-2021 due to DIARRHOEA, PYREXIA and VOMITING. On 04-Sep-2021, PYREXIA (Fever/Fever), VOMITING (Vomiting) and DIARRHOEA (Intense diarrhea) had resolved.            No concomitant medication was provided. No treatment medication was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-044968 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache 2nd shoot; Joint pain / Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease and Central nervous system inflammation (Central nervous system inflammation syndrome as a consequence of Lyme disease).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache 2nd shoot) and ARTHRALGIA (Joint pain / Arthralgia) had resolved.            Concomitant product use was not provided.   This case was linked to MOD-2021-308016 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Moderate sore arm; Took two naps; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Moderate sore arm) and SOMNOLENCE (Took two naps) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (Moderate sore arm) and SOMNOLENCE (Took two naps). At the time of the report, MYALGIA (Moderate sore arm) and SOMNOLENCE (Took two naps) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-307983, MOD-2021-308023 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache booster; Joint pain booster; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease and Central nervous system inflammation (Central nervous system inflammation syndrome).   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster). On 04-Sep-2021, HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster) had resolved.            Patient stated that the symptoms subsided in the night of the 4-Sep-2021.   Patient did not took Tylenol that was prescribed by a pharmacist.   This case was linked to MOD-2021-308000 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Moderate sore arm; Took two naps; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Took two naps) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced SOMNOLENCE (Took two naps). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Took two naps) outcome was unknown.            No concomitant medication were reported.   This case was linked to MOD-2021-307981, MOD-2021-308039 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: minor sore arm; Could barely get out of bed; Was wiped out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2020, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, PAIN IN EXTREMITY (minor sore arm), ASTHENIA (Could barely get out of bed) and FATIGUE (Was wiped out) had resolved.            No concomitant medications were reported   This case was linked to MOD-2021-308014, MOD-2021-307983.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Interchange of vaccine products
Clinical narrative: after his Moderna vaccine which is his third shot since he already got 2 Pfizer doses; achy knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (achy knees) and INTERCHANGE OF VACCINE PRODUCTS (after his Moderna vaccine which is his third shot since he already got 2 Pfizer doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced ARTHRALGIA (achy knees). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (after his Moderna vaccine which is his third shot since he already got 2 Pfizer doses). At the time of the report, ARTHRALGIA (achy knees) and INTERCHANGE OF VACCINE PRODUCTS (after his Moderna vaccine which is his third shot since he already got 2 Pfizer doses) outcome was unknown.          Doses 1 and 2 were Pfizer and 3rd/booster was Moderna  No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: Could barely get out of bed; Minor sore arm; Was wiped out; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A, 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 03-Sep-2021, ASTHENIA (Could barely get out of bed), PAIN IN EXTREMITY (Minor sore arm) and FATIGUE (Was wiped out) had resolved.            No concomitant medications were given by the reporter.   This case was linked to MOD-2021-308020, MOD-2021-307981 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Muscle tightness, Myalgia
Clinical narrative: Neck tie; General body pain; Headache; 104F (diminished to 103F); extreme Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) 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 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 and 103 (High) diminished to 103 F after taking Tylenol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Neck tie; General body pain; Headache; 104F (diminished to 103F); extreme Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) 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 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 and 103 (High) diminished to 103 F after taking Tylenol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Orgasm abnormal
Clinical narrative: Random orgasms; This spontaneous case was reported by a consumer and describes the occurrence of ORGASM ABNORMAL (Random orgasms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced ORGASM ABNORMAL (Random orgasms). At the time of the report, ORGASM ABNORMAL (Random orgasms) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Headache
Clinical narrative: She still got the second shot and now she feels even worse; still with low energy; occasional headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches) 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 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches). At the time of the report, CONDITION AGGRAVATED (She still got the second shot and now she feels even worse), ASTHENIA (still with low energy) and HEADACHE (occasional headaches) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-307139 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion, Erythema, Pain, Skin discolouration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blister), SKIN DISCOLOURATION (discoloration of arm), PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination.No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like). On 05-Sep-2021, the patient experienced BLISTER (blister) and SKIN DISCOLOURATION (discoloration of arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BLISTER (blister), SKIN DISCOLOURATION (discoloration of arm), PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like) outcome was unknown.No Concomitant informations were reported.Most recent FOLLOW-UP information incorporated above includes:On 07-Sep-2021: Patient date of birth added, vaccination information , date and details added, events added.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nasopharyngitis, Pyrexia, Sinus disorder
Clinical narrative: head cold; sinus issues; congestion; mild to really bad headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion), HEADACHE (mild to really bad headaches) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 002A21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PYREXIA (fever). On 02-Sep-2021, the patient experienced NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion) and HEADACHE (mild to really bad headaches). The patient was treated with IBUPROFEN for Fever, at a dose of UNK, as necessary. At the time of the report, NASOPHARYNGITIS (head cold), SINUS DISORDER (sinus issues), NASAL CONGESTION (congestion), HEADACHE (mild to really bad headaches) and PYREXIA (fever) outcome was unknown.            No concomitant drug details were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: States after the 1st two doses, she had little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (States after the 1st two doses, she had little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (high blood pressure) and Kidney failure (stage 3 kidney failure).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (States after the 1st two doses, she had little sore arm). At the time of the report, MYALGIA (States after the 1st two doses, she had little sore arm) outcome was unknown.            Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-308166, MOD-2021-308184  (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain) in an 86-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 (little pain). At the time of the report, PAIN (little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient had no event with Dose 2 and he was due for shingles, flu shot, and also interested in taking the booster shot.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (body ache) and HEADACHE (headache). At the time of the report, MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment drugs were not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Says he barely had any side effects with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Says he barely had any side effects with the first dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, SILODOSIN, OMEPRAZOLE, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), ASCORBIC ACID (VITAMIN C ACID) and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Says he barely had any side effects with the first dose). The patient was treated with PARACETAMOL (TYLENOL 8 HR ARTHRITIS PAIN) ongoing since an unknown date for Arthritic pains, at a dose of 650 mg. At the time of the report, VACCINATION COMPLICATION (Says he barely had any side effects with the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-308164, MOD-2021-308181.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever; Minor pain on the injection site; Minor fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergic to penicillin). Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE, SILODOSIN, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), VITAMIN C [ASCORBIC ACID], CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN and OMEPRAZOLE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL 8 HR ARTHRITIS PAIN) for Pain, at a dose of 650 mg. On 24-Feb-2021, PYREXIA (Low grade fever), VACCINATION SITE PAIN (Minor pain on the injection site), FATIGUE (Minor fatigue) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-308129, MOD-2021-308181 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: states after the 1st two doses, she had little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (states after the 1st two doses, she had little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 006M20A and 0451B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney failure (stage 3 kidney failure). Concurrent medical conditions included Blood pressure high (high blood pressure).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-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 MYALGIA (states after the 1st two doses, she had little sore arm). At the time of the report, MYALGIA (states after the 1st two doses, she had little sore arm) outcome was unknown.            No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-308184, MOD-2021-308108 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: less than 21 days administration of 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose). On 04-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 21 days administration of 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the dose 12 days early. Scheduled dose was supposed to be on the 15th.  No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Mass, Pruritus
Clinical narrative: big lump on the right arm, lump is size of golf ball, getting bigger,; lump is super hot; lump is super itchy; lump is red; This spontaneous case was reported by a nurse and describes the occurrence of MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.