chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced COVID-19 (Diagnosed with covid-19). At the time of the report, COVID-19 (Diagnosed with covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment information not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: Was a little congested with a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Was a little congested with a headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Was a little congested with a headache). At the time of the report, HEADACHE (Was a little congested with a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, COVID-19: negative (Negative) Negative. On 18-Apr-2021, COVID-19: positive (Positive) Positive. On 24-Apr-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash, Vomiting
Clinical narrative: Vomiting; Fever; Rash on chest (red dots); Small headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VOMITING (Vomiting), PYREXIA (Fever), RASH (Rash on chest (red dots)) and HEADACHE (Small headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Vaccination site rash
Clinical narrative: Arm hurt; rash at injection site; Tired; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0381421A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Stroke (Mini) in 1998. Concurrent medical conditions included Drug allergy (Eliquis, Xarelto, omeprazole, amiodarone, and pantoprazole.). Concomitant products included WARFARIN and LAMOTRIGINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas). At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092140 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092140:Second dose case.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: body ache and sore arm; headache; fever; sore throat; runny nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (body ache and sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: body ache and sore arm; headache; fever; sore throat; runny nose; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (body ache and sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), CHILLS (chills), MYALGIA (body ache and sore arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness & lightheadedness; Lightheadedness; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Dizziness & lightheadedness) and DIZZINESS (Lightheadedness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced DIZZINESS (Dizziness & lightheadedness) and DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Dizziness & lightheadedness) and DIZZINESS (Lightheadedness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication taken by the patient include multivitamins.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Exfoliative rash, Rash, Rash erythematous, Rash macular
Clinical narrative: Red rash; Macular rash; Scaly rash; Disseminated rash, global rash; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash). At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH MACULAR (Macular rash), EXFOLIATIVE RASH (Scaly rash) and RASH (Disseminated rash, global rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 was not applicable. Concomitant medication details was not provided by the reporter. Treatment details included none.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not given in over 42 days since first dose on 3Mar2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021). On 03-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose not given in over 42 days since first dose on 3Mar2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received on 27-MAY-2021 is not significant.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (knee pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (knee pain). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved and ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-091996 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster
Clinical narrative: Fatigue; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and FATIGUE (Fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). On 26-Apr-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, HERPES ZOSTER (Shingles) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant has been reported.  Treatment medication included unspecified antibiotics.   This case was linked to MOD-2021-092108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: non-significant followup was received on 28may-2021.no significant updates.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered 18 days after the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose). On 17-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 18 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.  No concomitant medications were provided by reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Getting worst at injection site; it is hot to the touch; Big red circle at injection site; It is really itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included CELECOXIB for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy). At the time of the report, VACCINATION SITE REACTION (Getting worst at injection site), VACCINATION SITE WARMTH (it is hot to the touch), VACCINATION SITE ERYTHEMA (Big red circle at injection site) and VACCINATION SITE PRURITUS (It is really itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature) and NO ADVERSE EVENT (No adverse event) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Administered a dose of the Moderna vaccine on 27April2021 that had been left at room temperature) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received from initial reporter: The reporter confirmed that the patient not experienced any adverse event due to medication error
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Peripheral swelling
Clinical narrative: became huge/ swollen; soreness / pain is on the outside muscle of the arm; pain goes into the joint; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint). At the time of the report, PERIPHERAL SWELLING (became huge/ swollen), MYALGIA (soreness / pain is on the outside muscle of the arm) and ARTHRALGIA (pain goes into the joint) 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Joint swelling, Peripheral swelling, Rash erythematous, Swelling
Clinical narrative: hands and neck are swelled up; huge red rash on every joint; Neck swelling; threw up; couldn't able to eat; knee joints, elbows and ankles swelled up; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint) and SWELLING (Neck swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, PANTOPRAZOLE, TIZANIDINE HCL, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), LEVOTHYROXINE and VITAMIN D3.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced JOINT SWELLING (knee joints, elbows and ankles swelled up). On an unknown date, the patient experienced FEEDING DISORDER (couldn't able to eat), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up). At the time of the report, FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines include Prednisone, Anti-histamines, Benadryl  Action taken with mRNA-1273 in response to the event was unknown
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: hands and neck are swelled up; huge red rash on every joint; Neck swelling; threw up; couldn't able to eat; knee joints, elbows and ankles swelled up; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint) and SWELLING (Neck swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, PANTOPRAZOLE, TIZANIDINE HCL, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), LEVOTHYROXINE and VITAMIN D3.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced JOINT SWELLING (knee joints, elbows and ankles swelled up). On an unknown date, the patient experienced FEEDING DISORDER (couldn't able to eat), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up). At the time of the report, FEEDING DISORDER (couldn't able to eat), JOINT SWELLING (knee joints, elbows and ankles swelled up), PERIPHERAL SWELLING (hands and neck are swelled up), RASH ERYTHEMATOUS (huge red rash on every joint), SWELLING (Neck swelling) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines include Prednisone, Anti-histamines, Benadryl  Action taken with mRNA-1273 in response to the event was unknown
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Erythema, Injection site erythema, Peripheral swelling, Pruritus
Clinical narrative: blistering that moved to his right arm; left hand was swollen; bumps and itchiness up and down his entire left arm; redness at injection site; redness on bicep; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left hand was swollen), BLISTER (blistering that moved to his right arm), ERYTHEMA (redness on bicep), PRURITUS (bumps and itchiness up and down his entire left arm) and INJECTION SITE ERYTHEMA (redness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Deep vein thrombosis (DVT in both legs) and Penicillin allergy. Concomitant products included BUMETANIDE for Diuretic effect, POTASSIUM for Potassium supplementation, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and WARFARIN 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 10-Mar-2021, the patient experienced ERYTHEMA (redness on bicep) and INJECTION SITE ERYTHEMA (redness at injection site). On 12-Mar-2021, the patient experienced PRURITUS (bumps and itchiness up and down his entire left arm). On 15-Mar-2021, the patient experienced PERIPHERAL SWELLING (left hand was swollen). On 23-Apr-2021, the patient experienced BLISTER (blistering that moved to his right arm). At the time of the report, PERIPHERAL SWELLING (left hand was swollen), BLISTER (blistering that moved to his right arm), ERYTHEMA (redness on bicep), PRURITUS (bumps and itchiness up and down his entire left arm) and INJECTION SITE ERYTHEMA (redness at injection site) 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.   Treatment medication was generic cortisone cream   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information received on 28-MAY-2021. Contain significant information about medical history and product information. Outcome of events changed unknown to resolved.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus flare after both doses in left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus flare after both doses in left ear) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032B120A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (Patient has a 20 year history of Tinnitus and after the first dose, within an hour, it got really bad.).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (tinnitus flare after both doses in left ear). At the time of the report, TINNITUS (tinnitus flare after both doses in left ear) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.   .   This case was linked to MOD-2021-092079 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: feel sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (feel sick). At the time of the report, ILLNESS (feel sick) outcome was unknown. Not Provided          For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant and treatment medications were reported.   This case was linked to MOD-2021-091976 (Linked Report).; Sender's Comments:  MOD-2021-091976:Wife case
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: >35 days between doses; really fatigued after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose) 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, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days between doses) and FATIGUE (really fatigued after second dose) outcome was unknown.            NO CONCOMINANT AND TREATMENT MEDICATOPN WERE REPORTED
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Chills, Headache, Myalgia
Clinical narrative: chills; nausea; vomiting; stomach cramping; muscle aches; headache; fever; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle aches) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: chills; nausea; vomiting; stomach cramping; muscle aches; headache; fever; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea) and MYALGIA (muscle aches) in a female patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, ABDOMINAL PAIN (stomach cramping), CHEST PAIN (chest pain), CHILLS (chills), NAUSEA (nausea), MYALGIA (muscle aches), HEADACHE (headache), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dysstasia, Sitting disability
Clinical narrative: Felt dizzy; extreme back pain; Cannot stand; Cannot sit; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (extreme back pain), DYSSTASIA (Cannot stand), SITTING DISABILITY (Cannot sit) and DIZZINESS (Felt dizzy) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE (PEPCID AC), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ZINC and FOLIC ACID for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced BACK PAIN (extreme back pain), DYSSTASIA (Cannot stand) and SITTING DISABILITY (Cannot sit). On an unknown date, the patient experienced DIZZINESS (Felt dizzy). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at an unspecified dose and frequency. At the time of the report, BACK PAIN (extreme back pain), DYSSTASIA (Cannot stand), SITTING DISABILITY (Cannot sit) and DIZZINESS (Felt dizzy) outcome was unknown. Not Provided          Concomitant products included fish oil.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-051431 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-051431:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Peripheral swelling, Tenderness
Clinical narrative: Swollen arm; Arm turned red pinkish; Arm was tender; Normal soreness; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), MYALGIA (Normal soreness), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FAMOTIDINE, DEXLANSOPRAZOLE (DEXILANT), ESCITALOPRAM OXALATE (LEXAPRO) and ZALEPLON (SONATA ADAMED) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced MYALGIA (Normal soreness). On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender). On 21-Apr-2021, MYALGIA (Normal soreness) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Arm turned red pinkish) and TENDERNESS (Arm was tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication reported includes Ibuprofen.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Night sweats, Pyrexia, Somnolence
Clinical narrative: Flu like symptoms; Very Sleepy during the day; Soaked with Sweat at Night; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Very Sleepy during the day), NIGHT SWEATS (Soaked with Sweat at Night) and PYREXIA (fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Very Sleepy during the day), NIGHT SWEATS (Soaked with Sweat at Night) and PYREXIA (fever). On 23-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), SOMNOLENCE (Very Sleepy during the day) and NIGHT SWEATS (Soaked with Sweat at Night) had resolved. At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided          Treatment information not provided. Concomitant medications were not provided.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Tremor
Clinical narrative: Shaking; Pain in Arm; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR, PAIN IN EXTREMITY (Pain in Arm), and CHILLS in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 TREMOR, PAIN IN EXTREMITY, and CHILLS. At the time of the report, TREMOR, PAIN IN EXTREMITY, and CHILLS outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-091728, MOD-2021-092609.   Most recent FOLLOW-UP information incorporated above included, on 18-Jun-2021 follow-up document contains, No New Information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Felt sick; Achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and MYALGIA (Achy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt sick) and MYALGIA (Achy). At the time of the report, MALAISE (Felt sick) and MYALGIA (Achy) outcome was unknown. Not Provided          Action taken with mRNA-1273 moderna vaccine was not applicable. Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-091815 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091815:Crosse linked
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling hot
Clinical narrative: an issue with the heart; intense heat; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat) 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 CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat). At the time of the report, CARDIAC DISORDER (an issue with the heart) and FEELING HOT (intense heat) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.  Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-082280:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain
Clinical narrative: Slept a lot; Aches and pains; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), PAIN (Aches and pains) and FATIGUE (Feeling 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot), PAIN (Aches and pains) and FATIGUE (Feeling tired). At the time of the report, HYPERSOMNIA (Slept a lot), PAIN (Aches and pains) and FATIGUE (Feeling tired) outcome was unknown.            Concomitant medications were not reported.  No treatment details were provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: injection site felt warm; covid arm, reaction at the injection site (big rectangle area); injection site Itched; injection site turned red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site felt warm), VACCINATION SITE REACTION (covid arm, reaction at the injection site (big rectangle area)), VACCINATION SITE PRURITUS (injection site Itched) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site felt warm), VACCINATION SITE REACTION (covid arm, reaction at the injection site (big rectangle area)), VACCINATION SITE PRURITUS (injection site Itched) and VACCINATION SITE ERYTHEMA (injection site turned red). At the time of the report, VACCINATION SITE WARMTH (injection site felt warm), VACCINATION SITE REACTION (covid arm, reaction at the injection site (big rectangle area)), VACCINATION SITE PRURITUS (injection site Itched) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not provided concomitant drugs were not provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Off label use, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Her oncologist postponed the second dose; earache; bumps behind ears; severe sore throat feeling like two balls inside her throat; Injection site pain; Vaccination site bump and swelling; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (earache), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Vaccination site bump and swelling), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PHENYTOIN SODIUM (DILANTIN D.A.) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE SWELLING (Vaccination site bump and swelling). On 24-Mar-2021, the patient experienced EAR PAIN (earache), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat). On an unknown date, the patient experienced OFF LABEL USE (Her oncologist postponed the second dose). On 26-Mar-2021, EAR PAIN (earache), VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE SWELLING (Vaccination site bump and swelling), EAR DISCOMFORT (bumps behind ears) and OROPHARYNGEAL PAIN (severe sore throat feeling like two balls inside her throat) had resolved. At the time of the report, OFF LABEL USE (Her oncologist postponed the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include Benadryl cream for itching Ibuprofen for earache at ER Other Concomitant Medication was Zonosimide and radiotherapy( for Cancer).