chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Constipation, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse) and VOMITING (vomiting a few times) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042BDIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse), VOMITING (vomiting a few times), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), CONSTIPATION (constipation, unsure if it is from TUMS) and FEELING ABNORMAL (feels lousy and can't take it anymore). At the time of the report, ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse), VOMITING (vomiting a few times), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), CONSTIPATION (constipation, unsure if it is from TUMS) and FEELING ABNORMAL (feels lousy and can't take it anymore) outcome was unknown. Not Provided. 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. Treatment to the events given as Tylenol. This case was linked to MOD-2021-117955.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse) and VOMITING (vomiting a few times) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042BDIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse), VOMITING (vomiting a few times), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), CONSTIPATION (constipation, unsure if it is from TUMS) and FEELING ABNORMAL (feels lousy and can't take it anymore). At the time of the report, ILLNESS (very very sick), HEADACHE (extreme headache), PAIN IN EXTREMITY (both arms very very sore), NAUSEA (nausea, eating makes it worse), VOMITING (vomiting a few times), ABDOMINAL PAIN (abdominal cramps), DIARRHOEA (diarrhea), CONSTIPATION (constipation, unsure if it is from TUMS) and FEELING ABNORMAL (feels lousy and can't take it anymore) outcome was unknown. Not Provided. 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. Treatment to the events given as Tylenol. This case was linked to MOD-2021-117955.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itches; arm swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (arm swollen) and VACCINATION SITE ERYTHEMA (Red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-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 VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (arm swollen) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (arm swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: blood glucose high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood glucose high) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02A621A and 030M20A.) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LINAGLIPTIN (TRADJENTA), INSULIN DETEMIR (LEVEMIR), CHLORTHALIDONE, CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood glucose high). At the time of the report, BLOOD GLUCOSE INCREASED (blood glucose high) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, Glycosylated haemoglobin: 6.5 (High) High. On 08-Apr-2021, Glycosylated haemoglobin: 8.2 (High) High.         Patient had a readjustment in insulin pump settings and Issues lasted around 6 weeks after vaccination was noted.   This case was linked to MOD-2021-276362 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 4-Aug-2021 contains significant information. Event outcome changed to recovered/resolved
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: Diarrhea; Fatigue; Thrown up, described as vomited; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VOMITING (Thrown up, described as vomited) and NAUSEA (Nausea) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LOSARTAN and TEMAZEPAM for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), VOMITING (Thrown up, described as vomited) and NAUSEA (Nausea). On 12-Apr-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, FATIGUE (Fatigue), VOMITING (Thrown up, described as vomited) and NAUSEA (Nausea) outcome was unknown.        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.   He called his primary care physician about three or four days ago and was told that he does not know anything about the vaccine and there was nothing which he could tell the patient about the vaccine. The patient asks whether it is common for the reported symptoms to be lasting this long and asks is it safe for him to get the second dose, scheduled for next Monday 19Apr2021, with these ongoing symptoms.The patient grants permission for Safety follow up and grants permission for Safety to follow up with his health care professional. Treatment details include, the patient has not treated his symptoms
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site discolouration, Vaccination site rash
Clinical narrative: Discoloration like a bruise at the injection site; Raised rash on arm (red itchy lump)/Raised rash at injection site; Injection site redness; Injection site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site), VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, High cholesterol and Anxiety. Concomitant products included SERTRALINE HCL for Anxiety, PRAVASTATIN for Cholesterol, VITAMIN D [VITAMIN D NOS], VITAMIN D3, DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) and ASCORBIC ACID (ESTER C [ASCORBIC ACID]) for an unknown indication.    On 19-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness). On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 09-Apr-2021, VACCINATION SITE RASH (Raised rash on arm (red itchy lump)/Raised rash at injection site), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PRURITUS (Injection site itchiness) had resolved. On 23-Apr-2021, VACCINATION SITE DISCOLOURATION (Discoloration like a bruise at the injection site) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-080431 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Added information of second dose and new event Discoloration like a bruise at the injection site. On 23-Apr-2021: Reporter's phone number and email address, concomitant drugs , 2nd dose lot number and  stop date of Discoloration like a bruise at the injection site event. On 18-May-2021: Patient's demographic details, Patient's medical history, concomitant medication details, and outcome of events, Causality were updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Her arm is sore and swollen and a little hot; Her arm is sore and swollen and a little hot; Her arm is sore and swollen and a little hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot). At the time of the report, VACCINATION SITE WARMTH (Her arm is sore and swollen and a little hot), VACCINATION SITE PAIN (Her arm is sore and swollen and a little hot) and VACCINATION SITE SWELLING (Her arm is sore and swollen and a little hot) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt was supposed to receive 2nd dose of pfizer covid-19 vaccine. However, pt received moderna covid-19.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Joint range of motion decreased, Monoplegia, Muscular weakness
Clinical narrative: Lack of muscle control in the hand arm and shoulder Loss of sensation in the hand arm and shoulder Paralysis in the hand arm or shoulder  Sharp stabbing pain in shoulder. Numbness and tingling. Overall muscle weakness. Limited range of motions and movements.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sensory loss, Ultrasound Doppler
Clinical narrative: Lack of muscle control in the hand arm and shoulder Loss of sensation in the hand arm and shoulder Paralysis in the hand arm or shoulder  Sharp stabbing pain in shoulder. Numbness and tingling. Overall muscle weakness. Limited range of motions and movements.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Hypokinesia, Muscle disorder, Muscular weakness
Clinical narrative: Lack of muscle control in the hand arm and shoulder Loss of sensation in the hand arm and shoulder Paralysis in the hand arm or shoulder  Sharp stabbing pain in shoulder. Numbness and tingling. Overall muscle weakness. Limited range of motions and movements.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paralysis, Sensory loss
Clinical narrative: Lack of muscle control in the hand arm and shoulder Loss of sensation in the hand arm and shoulder Paralysis in the hand arm or shoulder  Sharp stabbing pain in shoulder. Numbness and tingling. Overall muscle weakness. Limited range of motions and movements.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath, chest tightening onset  approximately and hr to an 1hr and 15 mins after Pfizer  vaccine administered.   Oral steroidal treatment prescribed  Place on prednisone 50mg once a day for a total of 10 days
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: fever; chills; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) 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 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (headache). On 10-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, HEADACHE (headache), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) was resolving.            No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (received Moderna vaccine while positive with COVID-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007B21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 30, 2021, patient experienced inappropriate schedule of product administration (received Moderna vaccine while positive with COVID-19). On Mar 30, 2021, inappropriate schedule of product administration (received Moderna vaccine while positive with COVID-19) resolved. Diagnostic results: On Mar 27, 2021, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Fatigue, Mobility decreased, Oxygen saturation decreased
Clinical narrative: Diagnosed with Covid-19; Dehydrated; unable to lift his left arm for 2 to 4 days; oxygen at 92; vomitting; fever at 102.9 degrees Fahrenheit; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92) and VOMITING (vomitting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), GLYBURIDE, METFORMIN and LISINOPRIL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-073823 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073823:Crossed linked
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Diagnosed with Covid-19; Dehydrated; unable to lift his left arm for 2 to 4 days; oxygen at 92; vomitting; fever at 102.9 degrees Fahrenheit; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92) and VOMITING (vomitting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), GLYBURIDE, METFORMIN and LISINOPRIL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue). On 05-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19), DEHYDRATION (Dehydrated), MOBILITY DECREASED (unable to lift his left arm for 2 to 4 days), OXYGEN SATURATION DECREASED (oxygen at 92), VOMITING (vomitting), PYREXIA (fever at 102.9 degrees Fahrenheit) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-073823 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073823:Crossed linked
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Two doses of vaccine at interval of 4 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Two doses of vaccine at interval of 4 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported patients has been accidently given 2 doses at interval of 4 days. No concomitant medications were reported. Treatment information was not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication, Vaccination site haemorrhage
Clinical narrative: arm was killing her; has bleed so much from the shot; when she wipped the site, there were blood clots on her napkin; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, 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 was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin). At the time of the report, PAIN IN EXTREMITY (arm was killing her), VACCINATION SITE HAEMORRHAGE (has bleed so much from the shot) and VACCINATION COMPLICATION (when she wipped the site, there were blood clots on her napkin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported. Treatment details were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle fatigue, Pain in extremity
Clinical narrative: terrible leg pains every night, legs are throbbing; she can't sleep, she can't nap; legs are achy; legs feel fatigued; extreme pain in her right foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in her right foot), PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in her right foot). On an unknown date, the patient experienced PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued). At the time of the report, PAIN IN EXTREMITY (extreme pain in her right foot), PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypoaesthesia, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: nauseous; neck/base of neck; numbness; pain; deep ache; broken collar bone; golf ball; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (golf ball), BONE PAIN (broken collar bone), MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (golf ball) and VACCINATION SITE SWELLING (swelling). On 25-Mar-2021, the patient experienced BONE PAIN (broken collar bone). On 26-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness), PAIN (pain) and PAIN (deep ache). On 10-Apr-2021, the patient experienced NAUSEA (nauseous). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 11-Apr-2021, NAUSEA (nauseous) had resolved. At the time of the report, PERIPHERAL SWELLING (golf ball), BONE PAIN (broken collar bone), MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness), PAIN (pain), PAIN (deep ache) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant medications were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide any causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non significant follow up.AE Contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: nauseous; neck/base of neck; numbness; pain; deep ache; broken collar bone; golf ball; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (golf ball), BONE PAIN (broken collar bone), MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (golf ball) and VACCINATION SITE SWELLING (swelling). On 25-Mar-2021, the patient experienced BONE PAIN (broken collar bone). On 26-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness), PAIN (pain) and PAIN (deep ache). On 10-Apr-2021, the patient experienced NAUSEA (nauseous). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 11-Apr-2021, NAUSEA (nauseous) had resolved. At the time of the report, PERIPHERAL SWELLING (golf ball), BONE PAIN (broken collar bone), MUSCULOSKELETAL STIFFNESS (neck/base of neck), HYPOAESTHESIA (numbness), PAIN (pain), PAIN (deep ache) and VACCINATION SITE SWELLING (swelling) outcome was unknown.            No concomitant medications were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide any causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non significant follow up.AE Contact information updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Headache, Nausea, Pain
Clinical narrative: Fell back into bed; Achiness/sore; Headache; Nausea; Dizziness; Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus (He was wearing a hearing aid in his right ear, on a scale of 1-10 he stated 3-4 as previous condition.).    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack") and DIZZINESS (Dizziness). On 31-Mar-2021, the patient experienced FALL (Fell back into bed), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-075143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 05-Aug-2021 and included Non significant information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Fell back into bed; Achiness/sore; Headache; Nausea; Dizziness; Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus (He was wearing a hearing aid in his right ear, on a scale of 1-10 he stated 3-4 as previous condition.).    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack") and DIZZINESS (Dizziness). On 31-Mar-2021, the patient experienced FALL (Fell back into bed), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, TINNITUS (Tinnitus jumped to a 6-8/ the frequency would fluctuate "fizzle and crack"), FALL (Fell back into bed), DIZZINESS (Dizziness), PAIN (Achiness/sore), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-075143 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 05-Aug-2021 and included Non significant information.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (illness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (illness). At the time of the report, ILLNESS (illness) outcome was unknown. Not Provided          This case was linked to MOD21-073867 (E2B Linked Report).; Sender's Comments:  MOD21-073867:Mother case
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Soft tissue mass, Vaccination site pain
Clinical narrative: Left arm sore; Hurt so bad to move his neck; Behind his left ear to his left shoulder is so painful and feels knots; Behind his left ear to his left shoulder is so painful and feels knots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and U25A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots). At the time of the report, VACCINATION SITE PAIN (Left arm sore), NECK PAIN (Hurt so bad to move his neck), SOFT TISSUE MASS (Behind his left ear to his left shoulder is so painful and feels knots) and ARTHRALGIA (Behind his left ear to his left shoulder is so painful and feels knots) had resolved.            Concomitant medication information not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05 Aug 2021, Updated outcome for the events .
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Peripheral swelling, Swelling
Clinical narrative: Headache; Nauseated; Swollen arm of the injection; Red arm in same arm of the injection; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PERIPHERAL SWELLING (Swollen arm of the injection), ERYTHEMA (Red arm in same arm of the injection) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, LORATADINE, LEVOTHYROXINE, AMLODIPINE, SERTRALINE, GLIPIZIDE, CALCIUM and VITAMIN D3 for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and ERYTHEMA (Red arm in same arm of the injection). On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm of the injection). On 11-Apr-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseated). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, ERYTHEMA (Redness), SWELLING (Swelling) and ERYTHEMA (Red arm in same arm of the injection) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm of the injection), HEADACHE (Headache) and NAUSEA (Nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included centrum. Treatment details included paracetamol and ice usage.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: tired; muscle pain; headache; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache). On 15-Mar-2021, FATIGUE (tired), MYALGIA (muscle pain) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient got tired, muscle pain, and headache 1 hour right after that and it lasted for 3 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chromatopsia, Discomfort, Dyskinesia, Headache, Nausea
Clinical narrative: strange sensation in both eyes/whites in my eyes had reddish-brown tinge; "wave-like sensation between collarbone and upper breast on both sides; whites in my eyes had reddish-brown tinge; moved three-quarters across the chest from the left to the right; headache moving from the left side of her forehead to middle of her forehead; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge), DYSKINESIA (moved three-quarters across the chest from the left to the right) and HEADACHE (headache moving from the left side of her forehead to middle of her forehead) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATORVASTATIN, CYANOCOBALAMIN (B 12), ZINC, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH), COLECALCIFEROL (D-3), VITAMIN C [ASCORBIC ACID] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (headache moving from the left side of her forehead to middle of her forehead) and NAUSEA (nauseated). On an unknown date, the patient experienced OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge) and DYSKINESIA (moved three-quarters across the chest from the left to the right). On 25-Mar-2021, HEADACHE (headache moving from the left side of her forehead to middle of her forehead) and NAUSEA (nauseated) had resolved. At the time of the report, OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge) and DYSKINESIA (moved three-quarters across the chest from the left to the right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking B-1 for unknown indication. Patient treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: strange sensation in both eyes/whites in my eyes had reddish-brown tinge; "wave-like sensation between collarbone and upper breast on both sides; whites in my eyes had reddish-brown tinge; moved three-quarters across the chest from the left to the right; headache moving from the left side of her forehead to middle of her forehead; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge), DYSKINESIA (moved three-quarters across the chest from the left to the right) and HEADACHE (headache moving from the left side of her forehead to middle of her forehead) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, ATORVASTATIN, CYANOCOBALAMIN (B 12), ZINC, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH), COLECALCIFEROL (D-3), VITAMIN C [ASCORBIC ACID] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (headache moving from the left side of her forehead to middle of her forehead) and NAUSEA (nauseated). On an unknown date, the patient experienced OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge) and DYSKINESIA (moved three-quarters across the chest from the left to the right). On 25-Mar-2021, HEADACHE (headache moving from the left side of her forehead to middle of her forehead) and NAUSEA (nauseated) had resolved. At the time of the report, OCULAR DISCOMFORT (strange sensation in both eyes/whites in my eyes had reddish-brown tinge), DISCOMFORT ("wave-like sensation between collarbone and upper breast on both sides), CHROMATOPSIA (whites in my eyes had reddish-brown tinge) and DYSKINESIA (moved three-quarters across the chest from the left to the right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking B-1 for unknown indication. Patient treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash, Vaccination site swelling
Clinical narrative: rash on arm; swollen itchy band; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm), VACCINATION SITE SWELLING (swollen itchy band), FATIGUE (tiredness) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (headache). On 07-Apr-2021, the patient experienced RASH (rash on arm) and VACCINATION SITE SWELLING (swollen itchy band). The patient was treated with TRIAMCINOLONE ACETONIDE for Rash, at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency and DOXYCYCLINE for Rash, at an unspecified dose and frequency. On 01-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, RASH (rash on arm), VACCINATION SITE SWELLING (swollen itchy band) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included Statin. Treatment included ice for rash.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: weakness; high fever (103-104) for six days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days) in a 120-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days). At the time of the report, ASTHENIA (weakness) and PYREXIA (high fever (103-104) for six days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to an unknown age.