chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: unable to eat; weakness; Weight loss; chills; fever of 102 degrees F; nausea; tiredness; pain in arm; red ring around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site). On 22-Mar-2021, the patient experienced FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness). On 25-Mar-2021, FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 (Inconclusive) 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided. The patient was due for  second dose on 14Apr2021, but had concerns about getting the second dose due to the side effects patient was experienced after the first vaccine.; Sender'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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in foot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuroma (pain in the bottom of the foot, something to do with ligament, has the issue for last 6 years.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in foot). At the time of the report, PAIN IN EXTREMITY (Pain in foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Patient received cortisone shot in foot 06Apr2021. No concomitant medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Food allergy, Hypersensitivity, Injection site erythema, Injection site rash
Clinical narrative: allergy symptoms; sensitive to food; nauseous; rash on her face; Redness on the injection site; rash on the injection site; tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Consciousness loss (Due to her mast cell disorder that makes her really sensitive.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (tired, fatigue). On 29-Mar-2021, the patient experienced RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food) and NAUSEA (nauseous). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site), INJECTION SITE RASH (rash on the injection site), FATIGUE (tired, fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications includes Allergy medicine, thyroid medicine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 Contains Updated Patient demographic details, Anatomical Location, Added Concomitant Medications, Added new events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash
Clinical narrative: allergy symptoms; sensitive to food; nauseous; rash on her face; Redness on the injection site; rash on the injection site; tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Consciousness loss (Due to her mast cell disorder that makes her really sensitive.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (tired, fatigue). On 29-Mar-2021, the patient experienced RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food) and NAUSEA (nauseous). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site), INJECTION SITE RASH (rash on the injection site), FATIGUE (tired, fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications includes Allergy medicine, thyroid medicine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 Contains Updated Patient demographic details, Anatomical Location, Added Concomitant Medications, Added new events.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, CITALOPRAM, GLYBURIDE, LISINOPRIL, METOPROLOL, CLOPIDOGREL, ATORVASTATIN, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.   On 31-Mar-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 01-Apr-2021, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) had not resolved. Not Provided          For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches around the forehead after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches around the forehead after the 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches around the forehead after the 1st dose). At the time of the report, HEADACHE (headaches around the forehead after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was scheduled to receive 2nd shot after 4 weeks on 27Apr2021.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LEVOTHYROXINE for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). At the time of the report, PAIN IN EXTREMITY (soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment products included Prednisone 20mg, Azithromycin 500mg, Tylenol occasionally.   This case was linked to US-MODERNATX, INC.-MOD-2021-056276 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056276:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain
Clinical narrative: pain on lower back; pain across chest; pain between his shoulder blades/pain on hips/Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, APIXABAN (ELIQUIS) for Anticoagulant therapy, LOVASTATIN for Cholesterol, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Gastrooesophageal reflux disease, LEUPRORELIN ACETATE (LUPRON DEPOT) for Prostate cancer, LISINOPRIL, FUROSEMIDE, METFORMIN, METOPROLOL and ENZALUTAMIDE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain). At the time of the report, BACK PAIN (pain on lower back), CHEST PAIN (pain across chest) and ARTHRALGIA (pain between his shoulder blades/pain on hips/Knee pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment history was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: follow up information received on 07apr2021 . new concomitant medication added
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Diarrhea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 007N29A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Chronic kidney disease since 01-Jan-2012. Concomitant products included FAMOTIDINE from 01-Jan-2014 to an unknown date for Acid reflux (esophageal), SIMVASTATIN from 01-Jan-2014 to an unknown date for Blood cholesterol, APIXABAN (ELIQUIS) from 01-Oct-2019 to an unknown date for DVT, LEVOTHYROXINE SODIUM (SYNTHYROID) from 01-Jan-2010 to an unknown date for Thyroid disorder.   On 18-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) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Chills). On 03-Apr-2021, the patient experienced PYREXIA (Fever). On 04-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency and GATIFLOXACIN (GATOR) for Adverse event, at an unspecified dose and frequency. On 06-Apr-2021, DIARRHOEA (Diarrhea), CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demography, Medical history, vaccine Doses information, Concomitant and Treatment Information and Events outcome updated.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old was given the first dose of Moderna Covid19 Vaccine; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given the first dose of Moderna Covid19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given the first dose of Moderna Covid19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old was given the first dose of Moderna Covid19 Vaccine) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taken second vaccine prior to 18th birthday. No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant Follow-up appended patient second dose information were added.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient has tested positive after the first dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient has tested positive after the first dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient has tested positive after the first dose of vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient has tested positive after the first dose of vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Severe chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02521A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache) and CHILLS (Severe chills). On 31-Mar-2021, HEADACHE (Headache) and CHILLS (Severe chills) had resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ALLERGY MEDICATION in 2019. Concurrent medical conditions included Drug allergy since 2017, Food allergy since 2017 and Pollen allergy (dirt allergy) since 2017.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 04-Feb-2021, FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-002927 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Swollen lymph node under his right armpit; Chills; Low grade fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Aches) and LYMPHADENOPATHY (Swollen lymph node under his right armpit) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Low grade fever) and MYALGIA (Aches). On 27-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under his right armpit). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Low grade fever), MYALGIA (Aches) and LYMPHADENOPATHY (Swollen lymph node under his right armpit) outcome was unknown. Not Provided      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.  No concomitant medication was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; 100.6°F fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (100.6°F fever) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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) .5 milliliter. On 30-Mar-2021, the patient experienced CHILLS (Chills). On 06-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (100.6°F fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (100.6°F fever) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 100.6 (Inconclusive) 100.6°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication  was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle tightness, Product dose omission issue
Clinical narrative: muscle tightness; bell headache; no second dose since 12Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021). At the time of the report, MUSCLE TIGHTNESS (muscle tightness), HEADACHE (bell headache) and PRODUCT DOSE OMISSION ISSUE (no second dose since 12Feb2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: CYP2C19 gene status assay, Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CYP2C19 gene status assay: unknown (Inconclusive) Ultra Rapid Metabolizer.         Other Lab data: Her reports states that she has CYP2C10*7 (p-806C7T). Treatment products include topical hydrocortisone on the rash and took zyrtec initially but then switched to Benadryl. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-062225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062225:First dose case
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided.   Reporter did not allow further contact
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Palpitations
Clinical narrative: sweating; palpitations; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PALPITATIONS (palpitations) and HEADACHE (headaches) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), PALPITATIONS (palpitations) and HEADACHE (headaches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating), PALPITATIONS (palpitations) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided.   Consumer only has seasonal allergies for which he takes "allergy pills", as needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Product colour issue
Clinical narrative: left arm was sore; received vaccine with a yellow brownish color; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was sore), PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) and FATIGUE (Fatigue) in a 52-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 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 PAIN IN EXTREMITY (left arm was sore), PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) and FATIGUE (Fatigue). On 17-Mar-2021, PRODUCT COLOUR ISSUE (received vaccine with a yellow brownish color) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was sore) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications and treatment were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd shot administered more than 36 days later; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot administered more than 36 days later) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot administered more than 36 days later). On 11-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot administered more than 36 days later) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, SARS-CoV-2 test positive
Clinical narrative: Flu-like achiness; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), FLECAINIDE, LEVOTHYROXINE, OMEPRAZOLE, METOPROLOL and AMLODIPINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Flu-like achiness) and MYALGIA (Soreness in injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Sore arm; Fatigue; Chills; Body ache; Headache; Fever 100.4F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea). 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, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever 100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fatigue; Chills; Body ache; Headache; Fever 100.4F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea). 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, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Body ache), HEADACHE (Headache), PYREXIA (Fever 100.4F) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 100.4 (Inconclusive) Fever 100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Impaired work ability, Insomnia, Muscular weakness
Clinical narrative: Hot and cold flashes; Couldn't sleep last night; Couldn't go to work due to fever; Joint pain in fingers, so it was difficult to grab things; Joint pain in fingers, so it was difficult to grab things; High fever, spike to 103 F; Body aches; Vaccine received in shoulder and it hurts very bad there; Swollen in shoulder at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things) and ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site). On 06-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F) and MYALGIA (Body aches). 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, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F), MYALGIA (Body aches), VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hot and cold flashes; Couldn't sleep last night; Couldn't go to work due to fever; Joint pain in fingers, so it was difficult to grab things; Joint pain in fingers, so it was difficult to grab things; High fever, spike to 103 F; Body aches; Vaccine received in shoulder and it hurts very bad there; Swollen in shoulder at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things) and ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disease, unspecified.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site). On 06-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F) and MYALGIA (Body aches). 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, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold flashes), INSOMNIA (Couldn't sleep last night), IMPAIRED WORK ABILITY (Couldn't go to work due to fever), MUSCULAR WEAKNESS (Joint pain in fingers, so it was difficult to grab things), ARTHRALGIA (Joint pain in fingers, so it was difficult to grab things), PYREXIA (High fever, spike to 103 F), MYALGIA (Body aches), VACCINATION SITE PAIN (Vaccine received in shoulder and it hurts very bad there) and VACCINATION SITE SWELLING (Swollen in shoulder at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: swollen injection arm; rash in 3 different areas of injection arm; rash in 3 different areas of injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in arm (patient stated a week ago their arm was hurting.).    On 16-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 INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm). At the time of the report, INJECTION SITE SWELLING (swollen injection arm), INJECTION SITE RASH (rash in 3 different areas of injection arm) and RASH (rash in 3 different areas of injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no medication report were provided no treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Influenza like illness, Myalgia
Clinical narrative: shortness of breath; chills; flu like symptoms; bodyaches; temperature 99 and was freezing; walking to other room had shortness of breath, is there all the time; had shortness of breath before but now is more severe, shortness of breath really increase; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches) and CHILLS (temperature 99 and was freezing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced DYSPNOEA (shortness of breath), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches), CHILLS (temperature 99 and was freezing), DYSPNOEA (walking to other room had shortness of breath, is there all the time) and DYSPNOEA (had shortness of breath before but now is more severe, shortness of breath really increase). At the time of the report, DYSPNOEA (shortness of breath), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (bodyaches), CHILLS (temperature 99 and was freezing), DYSPNOEA (walking to other room had shortness of breath, is there all the time) and DYSPNOEA (had shortness of breath before but now is more severe, shortness of breath really increase) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Myalgia, Paraesthesia
Clinical narrative: goes from the muscle and to the elbow and is feeling like a tingle; can't even sleep\cannot sleep because it's painful; muscle pain on left arm\pain goes from the muscle and to the elbow\nagging pain  almost like a tooth ache; tired and cannot sleep because it's painful; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (goes from the muscle and to the elbow and is feeling like a tingle), INSOMNIA (can't even sleep\cannot sleep because it's painful), MYALGIA (muscle pain on left arm\pain goes from the muscle and to the elbow\nagging pain  almost like a tooth ache), FATIGUE (tired and cannot sleep because it's painful) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (goes from the muscle and to the elbow and is feeling like a tingle), INSOMNIA (can't even sleep\cannot sleep because it's painful), MYALGIA (muscle pain on left arm\pain goes from the muscle and to the elbow\nagging pain  almost like a tooth ache), FATIGUE (tired and cannot sleep because it's painful) and ARTHRALGIA (Joint pain). At the time of the report, PARAESTHESIA (goes from the muscle and to the elbow and is feeling like a tingle), INSOMNIA (can't even sleep\cannot sleep because it's painful), MYALGIA (muscle pain on left arm\pain goes from the muscle and to the elbow\nagging pain  almost like a tooth ache), FATIGUE (tired and cannot sleep because it's painful) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment: cream (muscle relaxant) nothing seemed to work, Arm exercising 800 mg pills.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Red egg circle shape; Itching on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red egg circle shape) and PRURITUS (Itching on left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red egg circle shape) and PRURITUS (Itching on left arm). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE ERYTHEMA (Red egg circle shape) outcome was unknown and PRURITUS (Itching on left arm) had resolved.            No concomitant medications were given