chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ligament rupture
Clinical narrative: ligament in injection shoulder snapped; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT RUPTURE (ligament in injection shoulder snapped) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation NOS (Shoulder surgery in right shoulder) in 2015.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced LIGAMENT RUPTURE (ligament in injection shoulder snapped). At the time of the report, LIGAMENT RUPTURE (ligament in injection shoulder snapped) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications were cholesterol medication, blood pressure medication, prostate medication.  The treatment information was not given.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vertigo
Clinical narrative: Vertigo; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and FATIGUE (Tired) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and FATIGUE (Tired). At the time of the report, VERTIGO (Vertigo) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: swelling; redness; itchy; pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain). At the time of the report, SWELLING (swelling), ERYTHEMA (redness), PRURITUS (itchy) and PAIN (pain) 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 medications reported.  Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Myalgia, Night sweats
Clinical narrative: experiencing debilitating side effects; night sweats; lack of appetite; chills; extremely painful muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (experiencing debilitating side effects), NIGHT SWEATS (night sweats), DECREASED APPETITE (lack of appetite), CHILLS (chills) and MYALGIA (extremely painful muscle soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (experiencing debilitating side effects), NIGHT SWEATS (night sweats), DECREASED APPETITE (lack of appetite), CHILLS (chills) and MYALGIA (extremely painful muscle soreness). At the time of the report, ASTHENIA (experiencing debilitating side effects), NIGHT SWEATS (night sweats), DECREASED APPETITE (lack of appetite), CHILLS (chills) and MYALGIA (extremely painful muscle soreness) outcome was unknown.            No concomitant medications were reported No treatment medications were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Headache, Induration
Clinical narrative: Weakness; My arm was swollen; Hard; My right chest felt hard and swollen, like when you are breastfeeding; headache; Body ache; shoulder pain; It is itchy where the vaccine was given; Mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and VACCINATION SITE PRURITUS (It is itchy where the vaccine was given) in a 52-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.   On 23-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild arm pain). On 23-May-2021, the patient experienced VACCINATION SITE PRURITUS (It is itchy where the vaccine was given). 23-May-2021, the patient experienced ARTHRALGIA (shoulder pain). On 28-May-2021, the patient experienced MYALGIA (Body ache). On an unknown date, the patient experienced ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, VACCINATION SITE PAIN (Mild arm pain) had resolved. At the time of the report, ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding), VACCINATION SITE PRURITUS (It is itchy where the vaccine was given), MYALGIA (Body ache), HEADACHE (headache) and ARTHRALGIA (shoulder pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-200825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received contains updated event outcome from unknown to recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Weakness; My arm was swollen; Hard; My right chest felt hard and swollen, like when you are breastfeeding; headache; Body ache; shoulder pain; It is itchy where the vaccine was given; Mild arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and VACCINATION SITE PRURITUS (It is itchy where the vaccine was given) in a 52-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.   On 23-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild arm pain). On 23-May-2021, the patient experienced VACCINATION SITE PRURITUS (It is itchy where the vaccine was given). 23-May-2021, the patient experienced ARTHRALGIA (shoulder pain). On 28-May-2021, the patient experienced MYALGIA (Body ache). On an unknown date, the patient experienced ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, VACCINATION SITE PAIN (Mild arm pain) had resolved. At the time of the report, ASTHENIA (Weakness), PERIPHERAL SWELLING (My arm was swollen), INDURATION (Hard), CHEST DISCOMFORT (My right chest felt hard and swollen, like when you are breastfeeding), VACCINATION SITE PRURITUS (It is itchy where the vaccine was given), MYALGIA (Body ache), HEADACHE (headache) and ARTHRALGIA (shoulder pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-200825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received contains updated event outcome from unknown to recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: extremely dizzy; chills; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous). At the time of the report, DIZZINESS (extremely dizzy), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.            Other concomitant medications include blood pressure medications and water pills.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up received on 3-JUN-2021 contains significant information- update dosage information
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Neuralgia
Clinical narrative: Tiredness; sweaty; Nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain). On 10-May-2021, the patient experienced FATIGUE (Tiredness). On 09-May-2021, HYPERHIDROSIS (sweaty) and NEURALGIA (Nerve pain) had resolved. At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has been treating the pain with steroid dose packs given by their chiropractor. No concomitant medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy flow of my period with blob of blood; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy flow of my period with blob of blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported. for mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessment.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oral pain
Clinical narrative: Blisters in mouth/mouth broke out in blisters; mouth broke out in blisters and is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in May 2021. Concomitant products included AMLODIPINE for an unknown indication.    On 21-May-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 ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore). At the time of the report, ORAL MUCOSAL BLISTERING (Blisters in mouth/mouth broke out in blisters) and ORAL PAIN (mouth broke out in blisters and is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized for pneumonia one week before vaccine and received antibiotics for treatment of the pneumonia. Patient then took oral antibiotic for treatment of the rash and blisters too. Patient has appointment with her primary care doctor 03-Jun-2021.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Nasopharyngitis, Neck pain
Clinical narrative: pain in neck; pain travels from shoulder to Spine; stiffness and pain in neck; head cold; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck), NASOPHARYNGITIS (head cold), NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck) and NASOPHARYNGITIS (head cold). On an unknown date, the patient experienced NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine). On 06-May-2021, NASOPHARYNGITIS (head cold) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness and pain in neck), NECK PAIN (pain in neck) and ARTHRALGIA (pain travels from shoulder to Spine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unspecified allergy medication.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-Significant follow up received on 30-jun-2021. patient date of birth was added
Sex: U
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: I'm feeling like going to faint every time I try to get up from my bed, or stay stand up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up) 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 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up). At the time of the report, PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms). At the time of the report, VACCINATION COMPLICATION (Is it safe to take PII(36):ATMaPlF6kgvWjcX to help with side effects after dose number 2/is ok to help elevate symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient took the second dose of the vaccine >35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient took the second dose of the vaccine >35 days after the first dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient took the second dose of the vaccine >35 days after the first dose). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient took the second dose of the vaccine >35 days after the first dose) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-significant follow up. Patient initials updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: lump at the injection site; Injection site warm to the touch; itchy  at the injection site; Redness at the injection site; raised surface at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Jun-2021, the patient experienced VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (raised surface at the injection site). On 28-May-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (raised surface at the injection site) outcome was unknown.        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 medications were not provided by reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: lump at the injection site; Injection site warm to the touch; itchy  at the injection site; Redness at the injection site; raised surface at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Jun-2021, the patient experienced VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (raised surface at the injection site). On 28-May-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE MASS (lump at the injection site), VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE PRURITUS (itchy  at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (raised surface at the injection site) outcome was unknown.        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 medications were not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Chills, Dyspnoea, Gait disturbance
Clinical narrative: couldn't eat or taste; arm swollen the size of a cantaloupe; felt like she had covid; out of breathe; couldn't walk; excruciating pain in feet and hands; shoulder feels heavy; shoulder feels like bumblebees are inside; chills; muscle pain in right shoulder; fever; head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid) and DYSPNOEA (out of breathe) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On 30-Apr-2021, the patient experienced AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, NASOPHARYNGITIS (head cold) had resolved. On 05-May-2021, AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-201287 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nasopharyngitis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: couldn't eat or taste; arm swollen the size of a cantaloupe; felt like she had covid; out of breathe; couldn't walk; excruciating pain in feet and hands; shoulder feels heavy; shoulder feels like bumblebees are inside; chills; muscle pain in right shoulder; fever; head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid) and DYSPNOEA (out of breathe) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On 30-Apr-2021, the patient experienced AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, NASOPHARYNGITIS (head cold) had resolved. On 05-May-2021, AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-201287 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: couldn't eat or taste; arm swollen the size of a cantaloupe; felt like she had covid; out of breathe; couldn't walk; excruciating pain in feet and hands; shoulder feels heavy; shoulder feels like bumblebees are inside; chills; muscle pain in right shoulder; fever; head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid) and DYSPNOEA (out of breathe) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced NASOPHARYNGITIS (head cold). On 30-Apr-2021, the patient experienced AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Apr-2021, NASOPHARYNGITIS (head cold) had resolved. On 05-May-2021, AGEUSIA (couldn't eat or taste), PERIPHERAL SWELLING (arm swollen the size of a cantaloupe), SUSPECTED COVID-19 (felt like she had covid), DYSPNOEA (out of breathe), GAIT DISTURBANCE (couldn't walk), PAIN IN EXTREMITY (excruciating pain in feet and hands), MUSCULOSKELETAL DISCOMFORT (shoulder feels heavy), MUSCULOSKELETAL DISCOMFORT (shoulder feels like bumblebees are inside), CHILLS (chills), ARTHRALGIA (muscle pain in right shoulder) and PYREXIA (fever) had resolved.            This case was linked to MOD-2021-201287 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Nausea, Premenstrual pain
Clinical narrative: Severe menstrual cramping for 3 days before the menstrual cycle; Bad anxiety attack; Soreness of the Left arm/Soreness got worse during the night; Several headaches; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea) and ANXIETY (Bad anxiety attack) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea) and ANXIETY (Bad anxiety attack). On an unknown date, the patient experienced PREMENSTRUAL PAIN (Severe menstrual cramping for 3 days before the menstrual cycle). At the time of the report, VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea), ANXIETY (Bad anxiety attack) and PREMENSTRUAL PAIN (Severe menstrual cramping for 3 days before the menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated she is not sure about receiving the second dose as scheduled on 4th June 2021, patient  wants to know whether she has to restart the vaccination series if she did not receive the vaccine on the scheduled date. No Treatment and Concomitant medications were reported
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe menstrual cramping for 3 days before the menstrual cycle; Bad anxiety attack; Soreness of the Left arm/Soreness got worse during the night; Several headaches; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea) and ANXIETY (Bad anxiety attack) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C71A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea) and ANXIETY (Bad anxiety attack). On an unknown date, the patient experienced PREMENSTRUAL PAIN (Severe menstrual cramping for 3 days before the menstrual cycle). At the time of the report, VACCINATION SITE PAIN (Soreness of the Left arm/Soreness got worse during the night), HEADACHE (Several headaches), CHILLS (Chills), NAUSEA (Nausea), ANXIETY (Bad anxiety attack) and PREMENSTRUAL PAIN (Severe menstrual cramping for 3 days before the menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated she is not sure about receiving the second dose as scheduled on 4th June 2021, patient  wants to know whether she has to restart the vaccination series if she did not receive the vaccine on the scheduled date. No Treatment and Concomitant medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain
Clinical narrative: experiencing pain in his left side; Almost feels like a broken rib; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib). At the time of the report, PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (very itchy rash) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 007M2012 and 010A21A) for COVID-19 immunization. No medical history reported. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritic rash (very itchy rash). At the time of the report, pruritic rash (very itchy rash) outcome: unknown. Reportedly, patient had no other adverse events; and not even rash after the second dose. Concomitant medication and treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the 2nd dose was given 10 days too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose was given 10 days too early) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005c21A and 045B21A) for COVID-19 vaccination.     Concomitant products included NICOTINE for Smoking cessation therapy, BENZTROPINE [BENZATROPINE], BISACODYL, DOCUSATE, HALOPERIDOL, HALOPERIDOL DECANOATE, LITHIUM CARBONATE and POLYETHYLENE GLYCOL [MACROGOL] for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose was given 10 days too early). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the 2nd dose was given 10 days too early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: Leakage at injection site (clear to clear-yellowish); This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and #006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-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 02-Jun-2021, the patient experienced VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)). At the time of the report, VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Couldn't eat or taste; Excruciating pain in feet and hands; Couldn't eat or taste; Arm swollen the size of a cantaloupe; Felt like she had covid; Out of breathe; Couldn't walk; Fever; Chills; Muscle pain in right shoulder; Shoulder feels heavy; Shoulder feels like bumblebees are inside; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe) and FEELING ABNORMAL (Felt like she had covid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg three times a day. On 05-May-2021, DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside) outcome was unknown.            This case was linked to MOD-2021-201239 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Couldn't eat or taste; Excruciating pain in feet and hands; Couldn't eat or taste; Arm swollen the size of a cantaloupe; Felt like she had covid; Out of breathe; Couldn't walk; Fever; Chills; Muscle pain in right shoulder; Shoulder feels heavy; Shoulder feels like bumblebees are inside; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe) and FEELING ABNORMAL (Felt like she had covid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg three times a day. On 05-May-2021, DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside) outcome was unknown.            This case was linked to MOD-2021-201239 (Patient Link).