chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Vaccination complication
Clinical narrative: strong reaction; very uncomfortable to sleep; past her due date for their second dose; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced strong reaction (Vaccination complication) and very uncomfortable to sleep (insomnia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: G12M20A) intramuscularly for prophylaxis of COVID-19 infection.    After receiving the vaccine, on an unspecified date, the patient experienced a strong reaction to it. The patient did not have to go to the doctor, but it was very uncomfortable to sleep. The patient was past her due date for her second dose (inappropriate schedule of vaccine administered). Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, strong reaction, very uncomfortable to sleep and past her due date for their second dose were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Little fever with the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever with the first vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cataract.    On 25-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 PYREXIA (Little fever with the first vaccine). At the time of the report, PYREXIA (Little fever with the first vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-024075 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received suspect onset date and reporter contact details updated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Paraesthesia, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: Tingling feet/hands; Muscle strain; Vaccination site reaction; Vaccination site rash; Vaccination site erythema; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema). At the time of the report, PARAESTHESIA (Tingling feet/hands) and MUSCLE STRAIN (Muscle strain) had resolved and VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema) 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 provided as antibiotic cream.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Tingling feet/hands; Muscle strain; Vaccination site reaction; Vaccination site rash; Vaccination site erythema; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema). At the time of the report, PARAESTHESIA (Tingling feet/hands) and MUSCLE STRAIN (Muscle strain) had resolved and VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema) 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 provided as antibiotic cream.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Little soreness at the injection site; arm swelled at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site). In February 2021, VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.The patient  applied baking soda with water which resolved the reaction.    This case was linked to MOD-2021-077634 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine aggravated.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported.  Treatment information included, ibuprofen was provided.   This case was linked to MOD-2021-011727 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin burning sensation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist). At the time of the report, SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) outcome was unknown.            No treatment information reported.   This case was linked to MOD-2021-049994 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Palmar erythema, Peripheral swelling, Rash
Clinical narrative: swollen palm; Red palm; rash around neck, behind ears and in the chest; tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen palm), PALMAR ERYTHEMA (Red palm), RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) in a 62-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 31-Jan-2021, the patient experienced FATIGUE (tiredness) and CHILLS (Chills). On 01-Feb-2021, the patient experienced RASH (rash around neck, behind ears and in the chest). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm). On 03-Feb-2021, RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Live follow up received on 10-May-2021: No new information was received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Felt cold; headache; mild body aches; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever). At the time of the report, NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101 degrees Farenheight.         No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Headache, Nausea
Clinical narrative: ER for headache; ER for dehydration; dizziness; rash; fever; chills; extreme headache; nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Traumatic brain injury (Patient was involved in car accident in 2012) and Orthopedic procedure (Patient has multiple plates throughout her body).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.). On 10-Mar-2021, the patient experienced DEHYDRATION (ER for dehydration). On 15-Mar-2021, the patient experienced HEADACHE (ER for headache). At the time of the report, DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: ER for headache; ER for dehydration; dizziness; rash; fever; chills; extreme headache; nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Traumatic brain injury (Patient was involved in car accident in 2012) and Orthopedic procedure (Patient has multiple plates throughout her body).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.). On 10-Mar-2021, the patient experienced DEHYDRATION (ER for dehydration). On 15-Mar-2021, the patient experienced HEADACHE (ER for headache). At the time of the report, DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: weakness; fever; chills; a little sore in right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021 and was forwarded to the company on 22-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore in right arm), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little sore in right arm). On 14-Mar-2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). On 19-Mar-2021, ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (a little sore in right arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 98.8 (High) 98.8 Degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Intramuscular) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: a red rash, around the injection area; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE RASH (a red rash, around the injection area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Graves' disease and Arthritis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (a red rash, around the injection area). At the time of the report, VACCINATION SITE RASH (a red rash, around the injection area) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Nausea; Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, METFORMIN and LISINOPRIL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). On 21-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and NAUSEA (Nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Dizziness, Pain in extremity
Clinical narrative: lightheadedness; pain in arm; dizzy; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and Manual therapy (hot and cold compress) for Pain in extremity. On 20-Mar-2021, DIZZINESS (lightheadedness), DIZZINESS (dizzy) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ). Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site). At the time of the report, RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included topical hydrocortisone.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash look like a burn; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash look like a burn) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash look like a burn). At the time of the report, RASH (Rash look like a burn) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       About 12 hours later the first dose patient developed a rash that now looks like a burn 10 days later 19 Mar 2021. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: No new information.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue; Headache; Muscle pain; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in an elderly male 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fatigue; Headache; Muscle pain; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in an elderly male 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Squeezy in the stomach"; Little nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea). On 09-Mar-2021, ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) had resolved.            On  17 Mar 2021 again the patient felt squeezy in the stomach and on 22 Mar 2021 the event got resolved. Concomitant medications was not provided by the reporter. Treatment for the events included Mepromazin
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness, Nasopharyngitis
Clinical narrative: cold; stiffness; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (light headedness). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness). At the time of the report, DIZZINESS (light headedness) had not resolved and NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Nausea
Clinical narrative: Shortness of breath; Nausea; Fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 18-Mar-2021, DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Peripheral swelling, Rash
Clinical narrative: Received 2nd dose 25 days after 1st dose; Red swollen palms; Rash around neck, behind ears and in the chest; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose), PERIPHERAL SWELLING (Red swollen palms), RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 0111J20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included CALCIUM and VITAMIN D3 for Osteoporosis.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). On 01-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash around neck, behind ears and in the chest). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) and PERIPHERAL SWELLING (Red swollen palms). On 03-Feb-2021, RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) had resolved and PERIPHERAL SWELLING (Red swollen palms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable  Treatment medicines were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No New Information On 16-Apr-2021: Updated Reporter Details, Patient medical history, Concomitant medicines, both Vaccines details, Updated outcome of the event from Unknown to Recovered On 10-May-2021: No NewInformation
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore Throat; Difficulty Breathing; Coughing; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M24A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Thyroid disorder and Diabetes.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills). At the time of the report, OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included medication for COPD, Diabetes and thyroid. The patient went to the Urgent Care and was treated for an upper respirator infection.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Poor quality sleep
Clinical narrative: Hard for him to sleep; Chills at night; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills at night and hard for him to sleep/poor quality sleep.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20 Mar 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced chills at night and it was hard for him to sleep. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events chills at night and hard for him to sleep was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 023M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and BUDESONIDE (PULMICORT) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches). At the time of the report, FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) outcome was unknown. Not Provided          Treatment was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: diarrhea; stomach pains; vomiting; nausea; muscle ache/body ache; joints pains; chills; fatigue and tiredness; itching at the site of the injection,; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,) and NAUSEA (nausea) in an 86-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.     The patient's past medical history included Diverticulitis. Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of the injection,). On 20-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included other psychotropic agents(not specified).The patient did not take any treatment medication.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pruritus, Vomiting
Clinical narrative: diarrhea; stomach pains; vomiting; nausea; muscle ache/body ache; joints pains; chills; fatigue and tiredness; itching at the site of the injection,; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,) and NAUSEA (nausea) in an 86-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.     The patient's past medical history included Diverticulitis. Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALPRAZOLAM (XANAX) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of the injection,). On 20-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included other psychotropic agents(not specified).The patient did not take any treatment medication.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Tenderness
Clinical narrative: tenderness; swelling on both arm pit (left arm, right arm auxillary swelling) and very painful; swelling on both arm pit (left arm, right arm auxillary swelling) and very painful; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TENDERNESS (tenderness), LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) outcome was unknown and LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.    This case was linked to MOD-2021-117053.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and event outcome was updated.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue; arm pain; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PYRIDOSTIGMINE BROMIDE and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain) and PAIN IN EXTREMITY (arm soreness). On 04-Mar-2021, the patient experienced FATIGUE (fatigue). On 05-Mar-2021, PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) 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.   The consumer reports to having underlying health conditions. The medical condition was unknown. the treatment medication was also unknown.
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Lymphadenopathy
Clinical narrative: adenopathy - swelling of nose, above the clavicle, near to shoulder; severe allergic reaction to food and drinks; A spontaneous report was received from a healthcare professional concerning  his wife, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy).  The patient's medical history was not provided. The relevant concomitant medications use was not reported.  On 29 Dec 2020, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unspecified date, after vaccination the patient experienced adenopathy-swelling of nose, swelling above the clavicle, swelling near to shoulder and had severe allergic reactions to food and drinks. The patient has been to the emergency room twice and has seen a local immunologist.  Treatment for the event was provided included prednisone.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy), were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 008B212A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown. Not Provided          Concomitant product information was not provided.  Treatment information was not provided.    This case was linked to MOD-2021-260311 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Second dose details added.