chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. International peer review. 2021     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product.  Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: 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.   Author comment clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-245527, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen gums/Blisters; Jaw pain, poping, locking, chewing, opening mouth and yawning problem; Fatigue; Fever; Chills; Headache; Swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Swollen gums/Blisters), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands). 30-Apr-2021, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem). The patient was treated with Manual therapy (got mouthguard) for Temporomandibular joint syndrome. On 07-May-2021, BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands) had resolved. At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem) had not resolved.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Jaw pain started after two days of vaccination. Patient's primary doctor and dentist told her that might be TMJ.   This case was linked to MOD-2021-068490 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Temporomandibular joint syndrome
Clinical narrative: Swollen gums/Blisters; Jaw pain, poping, locking, chewing, opening mouth and yawning problem; Fatigue; Fever; Chills; Headache; Swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Swollen gums/Blisters), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands). 30-Apr-2021, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem). The patient was treated with Manual therapy (got mouthguard) for Temporomandibular joint syndrome. On 07-May-2021, BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands) had resolved. At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem) had not resolved.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Jaw pain started after two days of vaccination. Patient's primary doctor and dentist told her that might be TMJ.   This case was linked to MOD-2021-068490 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Dizziness, Fatigue, Gingival swelling
Clinical narrative: Blisters; Swollen gums; Dizziness; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 07-May-2021, BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.            No concomitant medication was reported  No treatment medication were provided.   This case was linked to MOD-2021-068600 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Blisters; Swollen gums; Dizziness; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever) and FATIGUE (Fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills). On 07-May-2021, BLISTER (Blisters), GINGIVAL SWELLING (Swollen gums), DIZZINESS (Dizziness), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.            No concomitant medication was reported  No treatment medication were provided.   This case was linked to MOD-2021-068600 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy, Positron emission tomogram
Clinical narrative: enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy on 28-May-2021. Concurrent medical conditions included Pre-diabetes since 01-Jan-2012 and Hypothyroidism since 01-Jan-2011.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY). On 03-Jul-2021, LYMPHADENOPATHY (enlarged lymph node on the left side of the neck, CAUSED FALSE POSITIVE IN NECK LYMPH NODE REQUIRING BIOSPY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Positron emission tomogram: abnormal (abnormal) saw an enlarged lymph node on the left side of the neck.. On 29-Jun-2021, Biopsy: abnormal (abnormal) positive biopsy in the uterus.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that, in April/May patient was given a PET scan where they found enlarged lymph node in neck (left side), same side as the shots were given. In Jun, then the patient had to under go a needle biopsy in order to rule out cancer. The biopsy came back negative. The patient's oncologist agreed that this was caused by the Covid shot.   No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU. medical history added.Event information updated. outcome of event recovered/resolved added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Debilitating tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Debilitating tinnitus) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No Medical History was provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-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 TINNITUS (Debilitating tinnitus). At the time of the report, TINNITUS (Debilitating tinnitus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Virus not detected.         No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow-up received and contains no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood pressure measurement, Body temperature, Dermatitis atopic, Erythema
Clinical narrative: Atopic dermatitis; itching on skin face and neck; Erythema; Urticaria; Heart rate increased; Itching and redness in eyes; Feeling Hot; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria) and HEART RATE INCREASED (Heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic interstitial cystitis, Irritable bowel syndrome, Sleep apnea, Prediabetes and Rhinitis. Concomitant products included BACLOFEN, CITALOPRAM HYDROBROMIDE (CITALOPRAM [CITALOPRAM HYDROBROMIDE]), METFORMIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication.   On 09-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 2- 3 tabs a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 4 shots and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 160/94 mmHg (High) 160/94. On 27-Jan-2021, Body temperature: 97.7 (normal) 97.7. On 27-Jan-2021, Heart rate: 91 (normal) 91. On 27-Jan-2021, Respiratory rate: 98 (abnormal) 98. On 17-Jun-2021, Biopsy: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-133981.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling hot, Heart rate, Heart rate increased, Pruritus
Clinical narrative: Atopic dermatitis; itching on skin face and neck; Erythema; Urticaria; Heart rate increased; Itching and redness in eyes; Feeling Hot; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria) and HEART RATE INCREASED (Heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic interstitial cystitis, Irritable bowel syndrome, Sleep apnea, Prediabetes and Rhinitis. Concomitant products included BACLOFEN, CITALOPRAM HYDROBROMIDE (CITALOPRAM [CITALOPRAM HYDROBROMIDE]), METFORMIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication.   On 09-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 2- 3 tabs a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 4 shots and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 160/94 mmHg (High) 160/94. On 27-Jan-2021, Body temperature: 97.7 (normal) 97.7. On 27-Jan-2021, Heart rate: 91 (normal) 91. On 27-Jan-2021, Respiratory rate: 98 (abnormal) 98. On 17-Jun-2021, Biopsy: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-133981.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Urticaria
Clinical narrative: Atopic dermatitis; itching on skin face and neck; Erythema; Urticaria; Heart rate increased; Itching and redness in eyes; Feeling Hot; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria) and HEART RATE INCREASED (Heart rate increased) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic interstitial cystitis, Irritable bowel syndrome, Sleep apnea, Prediabetes and Rhinitis. Concomitant products included BACLOFEN, CITALOPRAM HYDROBROMIDE (CITALOPRAM [CITALOPRAM HYDROBROMIDE]), METFORMIN and PENTOSAN POLYSULFATE SODIUM (ELMIRON) for an unknown indication.   On 09-Jan-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 2- 3 tabs a day; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at a dose of 4 shots and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) at an unspecified dose and frequency. At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis), PRURITUS (itching on skin face and neck), ERYTHEMA (Erythema), URTICARIA (Urticaria), HEART RATE INCREASED (Heart rate increased), EYE PRURITUS (Itching and redness in eyes) and FEELING HOT (Feeling Hot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Blood pressure measurement: 160/94 mmHg (High) 160/94. On 27-Jan-2021, Body temperature: 97.7 (normal) 97.7. On 27-Jan-2021, Heart rate: 91 (normal) 91. On 27-Jan-2021, Respiratory rate: 98 (abnormal) 98. On 17-Jun-2021, Biopsy: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-133981.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: nodule; This spontaneous case was reported by an other health care professional and describes the occurrence of NODULE (nodule) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental cleaning (Patient had dental cleaning within the last 6-12 months.). Previously administered products included for an unreported indication: INFLUENZA VACCINE (She had the flu shot in the fall of 2020.) in 2020. Concurrent medical conditions included Notalgia paresthetica. Concomitant products included TRAZODONE for Insomnia, GABAPENTIN for Notalgia paresthetica, POLY-L-LACTIC ACID (SCULPTRA AESTHETIC) from 07-Jun-2021 to an unknown date, HYALURONIC ACID (JUVEDERM), BOTULINUM TOXIN TYPE A (BOTOX), HYALURONIC ACID (RESTYLANE), HYALURONIC ACID, LIDOCAINE (RESTYLANE L) and BOTULINUM TOXIN TYPE A HAEMAGGLUTININ COMPLEX (DYSPORT) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced NODULE (nodule). At the time of the report, NODULE (nodule) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The HCP said to massage nodule 2x a day for 2 minutes for 2 weeks but the patient had been told by previous providers to do it 5 minutes a day 5 x for 5 weeks. Her husband who is a retired physician thinks it's about a 2-3 mm nodule. Patient has had Voluma, Vollure, in past. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Tinnitus
Clinical narrative: brain issue; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Barrett's esophagus on 15-Apr-2021. Concurrent medical conditions included Hypothyroidism since 01-Mar-2009 and Hypertension since 01-Mar-2006. Concomitant products included OMEPRAZOLE from 2012 to an unknown date for Gastroesophageal reflux, LISINOPRIL from 2006 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 2009 to an unknown date for Hypothyroidism.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced CEREBRAL DISORDER (brain issue). At the time of the report, TINNITUS (Tinnitus) and CEREBRAL DISORDER (brain issue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow up appended: Reporter address was added. The patient demography updated. Medical History included Hypothyroidism, Hypertension and Barrett's Esophagus were added. Suspected 2nd dose updated. Concomitant medications LEVOTHYROXIN, LISINOPRIL, OMEPRAZOLE were added. Event Tinnitis start date and outcome was updated and additional event brain issue was added.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: "My 15yr old daughter had her covid vaccine (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)). On 05-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE ("My 15yr old daughter had her covid vaccine (1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not reported.   Treatment information was not reported.   This case was linked to MOD-2021-211659 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: chills; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Left breast cancer).    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown. Not provided.          No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: light headed; diarrhea; hot around the injection site; hard around the injection site; Fever of 101.5 F; nauseated; headache; very red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site) and PYREXIA (Fever of 101.5 F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site). On 20-Mar-2021, DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site) had resolved.            Patient takes blood pressure medicines but no further information.  No concomitant medications are reported by the reporter. No treatment information is provided.   This case was linked to MOD-2021-056406, MOD-2021-247019.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: light headed; diarrhea; hot around the injection site; hard around the injection site; Fever of 101.5 F; nauseated; headache; very red around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site) and PYREXIA (Fever of 101.5 F) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site). On 20-Mar-2021, DIZZINESS (light headed), DIARRHOEA (diarrhea), VACCINATION SITE WARMTH (hot around the injection site), VACCINATION SITE INDURATION (hard around the injection site), PYREXIA (Fever of 101.5 F), NAUSEA (nauseated), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (very red around the injection site) had resolved.            Patient takes blood pressure medicines but no further information.  No concomitant medications are reported by the reporter. No treatment information is provided.   This case was linked to MOD-2021-056406, MOD-2021-247019.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes that looked like mosquito bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes that looked like mosquito bites) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes that looked like mosquito bites). At the time of the report, RASH (Rashes that looked like mosquito bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-247929, MOD-2021-247929, MOD-2021-236284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter stated that she received Pfizer vaccine not a daughter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter; This spontaneous case was reported by a consumer and describes the occurrence of RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter). At the time of the report, RASH (some people had rashes that looked like mosquito bites after receiving their Moderna vaccines/pastor's daughter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD21-115324, MOD-2021-236284, MOD-2021-247899, MOD-2021-247899, MOD-2021-236284 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received included no new information
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nauseous; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired) and NAUSEA (Nauseous) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Medical history is not reported.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced FATIGUE (Really tired). On 28-Apr-2021, the patient experienced NAUSEA (Nauseous). On 28-Apr-2021, FATIGUE (Really tired) and NAUSEA (Nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used by the patient includes MULTIVITAMIN for an unknown indication. No Treatment medication were reported.   This case was linked to MOD-2021-248381 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-Jul-2021 and contains no new information. On 09-Aug-2021: Follow-up received on 09-AUG-2021 included no new information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Didn't feel right; Slight body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Didn't feel right) and MYALGIA (Slight body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-031627 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Getting COVID After the Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Why does a magnet stick to my injection sight?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?). At the time of the report, VACCINATION SITE REACTION (Why does a magnet stick to my injection sight?) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: doesn't want to receive the second dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (doesn't want to receive the second dose of vaccine) 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 medication not provided.   Treatment medication not provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder- Left; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder- Left) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-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 ARTHRALGIA (Sore shoulder- Left). At the time of the report, ARTHRALGIA (Sore shoulder- Left) 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 No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2021-058103 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Off-Label Use (Under Age); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Patient medical history was not provided.  Concomitant products included ALBUTEROL [SALBUTAMOL], VENLAFAXINE HYDROCHLORIDE (EFEXOR) and VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE XR) for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)). On 06-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off-Label Use (Under Age)) 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 treatment information was provided.   This case was linked to MOD-2021-265390 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non significant follow-up appended : No new information added related to first dose.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Face injury, Skin discolouration, Skin injury, Swelling face
Clinical narrative: Side effect on the face; Swollen,it got bigger; Sort of dark looking\ side effect on her face and skin which is dark looking; It was very upsetting; Damage to their face; Damage to their skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting) and FACE INJURY (Damage to their face) in an 84-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.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin). At the time of the report, VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin) outcome was unknown.            No treatment medication details was reported.   This case was linked to MOD-2021-250415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and patient's contact details added, updated event information. On 10-Aug-2021: Follow -up received on 10-AUG-2021 contains Non Significant information On 12-Aug-2021: follow-up received and additional AE added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect on the face; Swollen,it got bigger; Sort of dark looking\ side effect on her face and skin which is dark looking; It was very upsetting; Damage to their face; Damage to their skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting) and FACE INJURY (Damage to their face) in an 84-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.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin). At the time of the report, VACCINATION COMPLICATION (Side effect on the face), SWELLING FACE (Swollen,it got bigger), SKIN DISCOLOURATION (Sort of dark looking\ side effect on her face and skin which is dark looking), DEPRESSED MOOD (It was very upsetting), FACE INJURY (Damage to their face) and SKIN INJURY (Damage to their skin) outcome was unknown.            No treatment medication details was reported.   This case was linked to MOD-2021-250415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and patient's contact details added, updated event information. On 10-Aug-2021: Follow -up received on 10-AUG-2021 contains Non Significant information On 12-Aug-2021: follow-up received and additional AE added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: swollen arm for days; had a high fever 14 hours after shot; very bad headache; tired; sore arm couldn't lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm couldn't lift it), PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm couldn't lift it) and FATIGUE (tired). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm for days), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm couldn't lift it) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient felt normal after 48 hours of shot and as of present day had no residual effects.   This case was linked to MOD-2021-016075.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received included E-mail, event outcome and added events.