chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Fatigue, Gait disturbance, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Rheumatoid arthritis flare up; Problems about washing, dressing and performing usual activities; Walking difficulty; Pain in toes/hand; fatigue Aggravated; anxious due to post vaccine rheumatoid arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems about washing, dressing, and performing usual activities), GAIT DISTURBANCE, ANXIETY, and PAIN IN EXTREMITY (toes and hand) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HUMIRA solution for injection for Rheumatoid arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On 27-Jan-2021, the patient started HUMIRA (Subcutaneous) 40 milligram every two weeks. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ANXIETY. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (washing, dressing, and performing usual activities), GAIT DISTURBANCE (Walking difficulty), PAIN IN EXTREMITY (toes and hand), and FATIGUE. At the time of the report, RHEUMATOID ARTHRITIS was resolving, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (washing, dressing, and performing usual activities), GAIT DISTURBANCE (Walking difficulty), ANXIETY, and PAIN IN EXTREMITY (toes and hand) outcome was unknown and FATIGUE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated, in 2021, the patient experienced problems about washing, dressing and performing usual activities, problems walking, felt more fatigued, anxious due to post vaccine rheumatoid arthritis flare, pain in toes/hand and pain in right knee/ankle. On 03-Apr-2021, the patient was anxious due to post vaccine rheumatoid arthritis flare up. Treatment of these events were not reported. Customer comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24MAY2021 contained no new information. Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Problems about washing, dressing and performing usual activities; Walking difficulty; Pain in toes/hand; fatigue Aggravated; anxious due to post vaccine rheumatoid arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems about washing, dressing, and performing usual activities), GAIT DISTURBANCE, ANXIETY, and PAIN IN EXTREMITY (toes and hand) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HUMIRA solution for injection for Rheumatoid arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On 27-Jan-2021, the patient started HUMIRA (Subcutaneous) 40 milligram every two weeks. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ANXIETY. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (washing, dressing, and performing usual activities), GAIT DISTURBANCE (Walking difficulty), PAIN IN EXTREMITY (toes and hand), and FATIGUE. At the time of the report, RHEUMATOID ARTHRITIS was resolving, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (washing, dressing, and performing usual activities), GAIT DISTURBANCE (Walking difficulty), ANXIETY, and PAIN IN EXTREMITY (toes and hand) outcome was unknown and FATIGUE had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated, in 2021, the patient experienced problems about washing, dressing and performing usual activities, problems walking, felt more fatigued, anxious due to post vaccine rheumatoid arthritis flare, pain in toes/hand and pain in right knee/ankle. On 03-Apr-2021, the patient was anxious due to post vaccine rheumatoid arthritis flare up. Treatment of these events were not reported. Customer comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24MAY2021 contained no new information. Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Decreased appetite, Emotional distress, Fatigue, Pain in extremity, Somnolence
Clinical narrative: Grogginess; No desire to eat; Tiredness; Arm pain; Mental distress/ worsening morning loopiness; This spontaneous case was reported by a physician and describes the occurrence of SOMNOLENCE (Grogginess), EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness), PAIN IN EXTREMITY (Arm pain), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for Plaque psoriasis.    The patient's past medical history included Back injury in 2007, Tobacco user (One pack per day.), Cigarette smoker and Cochlear implant. Previously administered products included for Product used for unknown indication: Hydrocodone. Family history included Deafness (Family history of Deafness) since an unknown date. Concurrent medical conditions included Type II diabetes mellitus since 2007 and Drug allergy (Hydrocodone allergy manifested by agitated).   On 30-Apr-2020, the patient started RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) (Subcutaneous) 150 mg. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 07-Apr-2021, the patient experienced SOMNOLENCE (Grogginess), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness). In April 2021, the patient experienced EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness). On 09-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. In April 2021, SOMNOLENCE (Grogginess), DECREASED APPETITE (No desire to eat) and FATIGUE (Tiredness) had resolved. At the time of the report, EMOTIONAL DISTRESS (Mental distress/ worsening morning loopiness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.No treatment information was provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Bleeding at injection site; growing bruise at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) and VACCINATION SITE BRUISING (growing bruise at injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) and VACCINATION SITE BRUISING (growing bruise at injection site). On 06-Apr-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (growing bruise at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not reported. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: While administering vaccine, needle went loose, vaccine sprayed out, went to her eye; while administering vaccine, needle went loose, vaccine sprayed out, went to her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye). On 27-Apr-2021, UNDERDOSE (While administering vaccine, needle went loose, vaccine sprayed out, went to her eye) and DEVICE CONNECTION ISSUE (while administering vaccine, needle went loose, vaccine sprayed out, went to her eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: shoulder pain; diarrhea all day; drank anything it felt like it was affecting her kidney; Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before; more tired then she normally is; entire body hurt; second dose was awful; real bad headaches; running a fever; nauseated; got up in the night and felt like she was going to throw up; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), ARTHRALGIA (shoulder pain) and DIARRHOEA (diarrhea all day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema. Concomitant products included Ventolin for her COPD and emphysema for Emphysema, prescribed vitamin D for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (entire body hurt), MOOD ALTERED (second dose was awful), HEADACHE (real bad headaches), PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up), CHILLS (chills) and FATIGUE (more tired then she normally is). On 27-Apr-2021, the patient experienced URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), ARTHRALGIA (shoulder pain), DIARRHOEA (diarrhea all day) and MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before). On 27-Apr-2021, PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up) and CHILLS (chills) had resolved. On 28-Apr-2021, URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), DIARRHOEA (diarrhea all day), HEADACHE (real bad headaches), MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before) and FATIGUE (more tired then she normally is) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment Tylenol every 4-5 hours yesterday, 27Apr   This case was linked to MOD-2021-096197 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: shoulder pain; diarrhea all day; drank anything it felt like it was affecting her kidney; Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before; more tired then she normally is; entire body hurt; second dose was awful; real bad headaches; running a fever; nauseated; got up in the night and felt like she was going to throw up; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), ARTHRALGIA (shoulder pain) and DIARRHOEA (diarrhea all day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema. Concomitant products included Ventolin for her COPD and emphysema for Emphysema, prescribed vitamin D for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (entire body hurt), MOOD ALTERED (second dose was awful), HEADACHE (real bad headaches), PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up), CHILLS (chills) and FATIGUE (more tired then she normally is). On 27-Apr-2021, the patient experienced URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), ARTHRALGIA (shoulder pain), DIARRHOEA (diarrhea all day) and MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before). On 27-Apr-2021, PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up) and CHILLS (chills) had resolved. On 28-Apr-2021, URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), DIARRHOEA (diarrhea all day), HEADACHE (real bad headaches), MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before) and FATIGUE (more tired then she normally is) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment Tylenol every 4-5 hours yesterday, 27Apr   This case was linked to MOD-2021-096197 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract discomfort
Clinical narrative: shoulder pain; diarrhea all day; drank anything it felt like it was affecting her kidney; Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before; more tired then she normally is; entire body hurt; second dose was awful; real bad headaches; running a fever; nauseated; got up in the night and felt like she was going to throw up; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), ARTHRALGIA (shoulder pain) and DIARRHOEA (diarrhea all day) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Emphysema. Concomitant products included Ventolin for her COPD and emphysema for Emphysema, prescribed vitamin D for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (entire body hurt), MOOD ALTERED (second dose was awful), HEADACHE (real bad headaches), PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up), CHILLS (chills) and FATIGUE (more tired then she normally is). On 27-Apr-2021, the patient experienced URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), ARTHRALGIA (shoulder pain), DIARRHOEA (diarrhea all day) and MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before). On 27-Apr-2021, PYREXIA (running a fever), NAUSEA (nauseated; got up in the night and felt like she was going to throw up) and CHILLS (chills) had resolved. On 28-Apr-2021, URINARY TRACT DISCOMFORT (drank anything it felt like it was affecting her kidney), PAIN (entire body hurt), MOOD ALTERED (second dose was awful), DIARRHOEA (diarrhea all day), HEADACHE (real bad headaches), MYALGIA (Muscle pain was the worst yesterday. It was the entire body. Never felt anytime like that before) and FATIGUE (more tired then she normally is) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment Tylenol every 4-5 hours yesterday, 27Apr   This case was linked to MOD-2021-096197 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of HUMIRA (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Impaired work ability
Clinical narrative: Sweats lasting approximately 8 hours; Unable to perform work related activities; Fatigue; Chills; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint Pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concurrent medical conditions included Seasonal allergy and Grass allergy (trees allergy). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 01-Jan-2020 to an unknown date for Allergy, ZINC for Product used for unknown indication, VITAMIN B COMPLEX from 01-Jan-2020 to an unknown date and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue) and CHILLS (Chills). 16-Mar-2021, the patient experienced ARTHRALGIA (Joint Pain). At the time of the report, HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint Pain) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included bed rest, increased fluids and ibuprofen.   This case was linked to MOD-2021-030216 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness, Vaccination site pain
Clinical narrative: extreme tenderness; extreme swelling; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007-M20A and 023-M20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy. Concurrent medical conditions included Cancer, Hypertension, Diabetes and Cholesterol. Concomitant products included LETROZOLE for Cancer, ROSUVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, CARVEDILOL for Heart rate abnormal, CHLORTHALIDONE for Hypertension.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 14-Mar-2021, TENDERNESS (extreme tenderness), SWELLING (extreme swelling) and VACCINATION SITE PAIN (pain at injection site) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-096459 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-096459:Second dose case
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Infection, Limb discomfort, Pain in extremity
Clinical narrative: cannot move the arm; left arm still inflamed; left arm is itchy; left arm is warm to touch; noticed a lump (caller unsure if its called lump) on her left underarm; could be a possible infection; left arm was red; left arm was tender; left arm was swollen; left arm was painful with pain scale of; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm was painful with pain scale of) and LIMB DISCOMFORT (cannot move the arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Shrimp). Concomitant products included BIOTIN, B-COMPLEX 2000 and ZINC for an unknown indication.    On 31-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 ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of). On 05-Apr-2021, the patient experienced LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection). The patient was treated with SULFAMETHOXAZOLE at a dose of 875mg/125mg and RIFAMPIN at a dose of 300 mg once a day. On 03-Apr-2021, ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of) had resolved. At the time of the report, LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received on 28-MAY-2021, no new information
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Swelling, Tenderness, Vaccination site warmth
Clinical narrative: cannot move the arm; left arm still inflamed; left arm is itchy; left arm is warm to touch; noticed a lump (caller unsure if its called lump) on her left underarm; could be a possible infection; left arm was red; left arm was tender; left arm was swollen; left arm was painful with pain scale of; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen), PAIN IN EXTREMITY (left arm was painful with pain scale of) and LIMB DISCOMFORT (cannot move the arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Shrimp). Concomitant products included BIOTIN, B-COMPLEX 2000 and ZINC for an unknown indication.    On 31-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 ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of). On 05-Apr-2021, the patient experienced LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection). The patient was treated with SULFAMETHOXAZOLE at a dose of 875mg/125mg and RIFAMPIN at a dose of 300 mg once a day. On 03-Apr-2021, ERYTHEMA (left arm was red), TENDERNESS (left arm was tender), PERIPHERAL SWELLING (left arm was swollen) and PAIN IN EXTREMITY (left arm was painful with pain scale of) had resolved. At the time of the report, LIMB DISCOMFORT (cannot move the arm), BURNING SENSATION (left arm still inflamed), PRURITUS (left arm is itchy), VACCINATION SITE WARMTH (left arm is warm to touch), SWELLING (noticed a lump (caller unsure if its called lump) on her left underarm) and INFECTION (could be a possible infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up received on 28-MAY-2021, no new information
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed 2nd dose appointment; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose appointment) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medicines was not reported by reporter  treatment information was not provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA and CHILLS in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HUMIRA for Rheumatoid arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA and CHILLS. At the time of the report, PYREXIA and CHILLS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-May-2021 and contains no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Epistaxis, Haematocrit, Headache
Clinical narrative: Right nostil has bloody scab; Everytime blow nose, blood comes out; Stomach is upset; Severe pain; Loose stools; Severe spinal pain/headache; Severe spinal pain/headache; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset) and PAIN (Severe pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SPINAL PAIN (Severe spinal pain/headache) and HEADACHE (Severe spinal pain/headache). On an unknown date, the patient experienced NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHOEA (Loose stools). At the time of the report, SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain), DIARRHOEA (Loose stools) and HEADACHE (Severe spinal pain/headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported. Patient received 2nd dose 03/20/21(Batch no.002B21A). Reporter stated that Right Nostril had a bloody scab that won't heal for a month and 1/2.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal crusting, Pain, Spinal pain
Clinical narrative: Right nostil has bloody scab; Everytime blow nose, blood comes out; Stomach is upset; Severe pain; Loose stools; Severe spinal pain/headache; Severe spinal pain/headache; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset) and PAIN (Severe pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced SPINAL PAIN (Severe spinal pain/headache) and HEADACHE (Severe spinal pain/headache). On an unknown date, the patient experienced NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain) and DIARRHOEA (Loose stools). At the time of the report, SPINAL PAIN (Severe spinal pain/headache), NASAL CRUSTING (Right nostil has bloody scab), EPISTAXIS (Everytime blow nose, blood comes out), ABDOMINAL DISCOMFORT (Stomach is upset), PAIN (Severe pain), DIARRHOEA (Loose stools) and HEADACHE (Severe spinal pain/headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haematocrit: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. No treatment information was reported. Patient received 2nd dose 03/20/21(Batch no.002B21A). Reporter stated that Right Nostril had a bloody scab that won't heal for a month and 1/2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness, Vaccination site pain
Clinical narrative: tenderness; swelling; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS, SWELLING, and VACCINATION SITE PAIN in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007-M20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node transplant. Concurrent medical conditions included Cancer. Concomitant products included CHLORTHALIDONE for Blood pressure high, LETROZOLE for Cancer, ROSUVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, CARVEDILOL for Heart rate low.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TENDERNESS, SWELLING, and VACCINATION SITE PAIN. On 09-Mar-2021, TENDERNESS and VACCINATION SITE PAIN had resolved and SWELLING outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Treatment medicines includes Excerdin.   This case was linked to US-MODERNATX, INC-MOD-2021-096372. Sender's Comments:  US-MODERNATX, INC-MOD-2021-096372: First dose case.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tired; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and FATIGUE (Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart valve disorders. Concomitant products included DIGOXIN for Heart valve disorders, VERAPAMIL and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PYREXIA (Low grade fever) and FATIGUE (Tired). At the time of the report, PYREXIA (Low grade fever) and FATIGUE (Tired) had resolved.            No treatment details were provided    This case was linked to MOD-2021-023665 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Oral mucosal blistering, Pain in extremity, Pyrexia
Clinical narrative: Blisters or sores on the roof of the mouth; Scratchy throat; Low grade fever; Fatigue; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth), THROAT IRRITATION (Scratchy throat), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FISH OIL, MULTIVITAMIN & MINERAL and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-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) (unknown route) 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 23-Apr-2021, the patient experienced FATIGUE (Fatigue). On 25-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth), THROAT IRRITATION (Scratchy throat) and PYREXIA (Low grade fever). On 23-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 24-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth) and THROAT IRRITATION (Scratchy throat) outcome was unknown and PYREXIA (Low grade fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature (36.1-37.2 degree Celsius): 37.2 degree Celsius High.         The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was not applicable.  Treatment information include Paracetamol.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Blisters or sores on the roof of the mouth; Scratchy throat; Low grade fever; Fatigue; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth), THROAT IRRITATION (Scratchy throat), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FISH OIL, MULTIVITAMIN & MINERAL and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 22-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) (unknown route) 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 23-Apr-2021, the patient experienced FATIGUE (Fatigue). On 25-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth), THROAT IRRITATION (Scratchy throat) and PYREXIA (Low grade fever). On 23-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 24-Apr-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ORAL MUCOSAL BLISTERING (Blisters or sores on the roof of the mouth) and THROAT IRRITATION (Scratchy throat) outcome was unknown and PYREXIA (Low grade fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature (36.1-37.2 degree Celsius): 37.2 degree Celsius High.         The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was not applicable.  Treatment information include Paracetamol.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid, Blood uric acid increased
Clinical narrative: Patient has worsened rising of uric acid in blood; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for Chronic lymphocytic leukemia.    The patient's past medical history included Splenomegaly in 2015, Kidney failure from 2016 to 2017, Palpitation, Dehydration and Splenectomy in 2015. Concurrent medical conditions included Penicillin allergy (Penicillin allergy manifested by rash), Mitral valve prolapse, Chronic lymphocytic leukemia and Alcoholic (Four glasses of wine a week, regularly, started 1968) since 1968. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for Chemotherapy, METOPROLOL for Palpitation, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 12-May-2020, the patient started VENETOCLAX (VENCLEXTA) (Oral) 20 milligram. On 12-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 10 milligram once a day. On 19-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 50 milligram once a day. On 26-May-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 100 milligram once a day. On 02-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 200 milligram once a day. On 09-Jun-2020, VENETOCLAX (VENCLEXTA) (Oral) dosage was changed to 400 milligram once a day. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood). At the time of the report, BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood uric acid: (High) Comprehensive metabolic panel- Uric acid is trending up. On 17-Mar-2021, Blood uric acid: Comprehensive metabolic panel- Uric acid is trending up. On an unknown date, Blood uric acid: (High) Unknown date, uric acid rising up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLOOD URIC ACID INCREASED (Patient has worsened rising of uric acid in blood) to be not related.    Concomitant medications included drug for prevention of pneumonia. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No new information.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination Site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Vaccination Site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination Site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination Site pain) was resolving. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Vaccination Site pain) to be possibly related.    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.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Pain
Clinical narrative: common cold; ache; This spontaneous case was reported by a physician and describes the occurrence of NASOPHARYNGITIS (common cold) and PAIN (ache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (common cold) and PAIN (ache). At the time of the report, NASOPHARYNGITIS (common cold) and PAIN (ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.