chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (Very itchy rash under her mask), RASH (Spread to her neck, shoulders, back and upper chest) and RASH (Rash on her legs extremely itchy only on the nights) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALENDRONATE SODIUM (FOSAMAX), NORTRIPTYLINE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced RASH PRURITIC (Very itchy rash under her mask) and RASH (Spread to her neck, shoulders, back and upper chest). On 07-Mar-2021, the patient experienced RASH (Rash on her legs extremely itchy only on the nights). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Very itchy rash under her mask), RASH (Spread to her neck, shoulders, back and upper chest) and RASH (Rash on her legs extremely itchy only on the nights) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow Up information received on 24-MAY-2021 contains no new information. On 15-Jul-2021: Follow up received and Event outcome was updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (had a hard time sleeping), PAIN (pain subsided), VACCINATION SITE PAIN (left arm started to get sore) and MYALGIA (left arm was still sore) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and METOPROLOL for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Mar-2021, the patient experienced INSOMNIA (had a hard time sleeping) and VACCINATION SITE PAIN (left arm started to get sore). On 07-Mar-2021, the patient experienced PAIN (pain subsided) and MYALGIA (left arm was still sore). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 06-Mar-2021 at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) on 07-Mar-2021 at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION SITE PAIN (left arm started to get sore) outcome was unknown. At the time of the report, INSOMNIA (had a hard time sleeping), PAIN (pain subsided) and MYALGIA (left arm was still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       To reduce the soreness in arm patient used ice .   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow up received on 23-JUN-2021 contains no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm; Achiness; Rash an inch down from injection site and 4 inches long; Tender to the touch, not painful; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 013M20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included HYDROXYZINE for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (Warm), PAIN (Achiness), VACCINATION SITE RASH (Rash an inch down from injection site and 4 inches long), VACCINATION SITE PAIN (Tender to the touch, not painful) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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 06-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) from 06-Mar-2021 to 07-Mar-2021 for Headache, at an unspecified dose and frequency. On 07-Mar-2021, HEADACHE (Headache) had resolved.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information was received on 25 May 2021 : included no new information.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausea; Vomitng; HEADACHE; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver metastases. Concurrent medical conditions included Colon cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) and PEMBROLIZUMAB (KEYTRUDA).    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 NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE). At the time of the report, NAUSEA (Nausea), VOMITING (Vomitng) and HEADACHE (HEADACHE) 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 information was not reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Inappropriate schedule of product administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Migraine, Product dose omission issue, Vaccination complication
Clinical narrative: side effects to vaccine 11 days later; Allergies; Missed second dose; migraine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose), MIGRAINE (migraine), VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Jan-2021, the patient experienced MIGRAINE (migraine). On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies). On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved. At the time of the report, MIGRAINE (migraine), VACCINATION COMPLICATION (side effects to vaccine 11 days later) and HYPERSENSITIVITY (Allergies) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Follow up received on 12-mar-2021, event was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: itchy on the arm/Itchiness from above the injection site to the elbow; Area was swollen on the arm; red area from above the injection site to the elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy on the arm/Itchiness from above the injection site to the elbow), PERIPHERAL SWELLING (Area was swollen on the arm) and VACCINATION SITE ERYTHEMA (red area from above the injection site to the elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PRURITUS (itchy on the arm/Itchiness from above the injection site to the elbow), PERIPHERAL SWELLING (Area was swollen on the arm) and VACCINATION SITE ERYTHEMA (red area from above the injection site to the elbow). The patient was treated with HYDROCORTISONE (CORTIZONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy on the arm/Itchiness from above the injection site to the elbow), PERIPHERAL SWELLING (Area was swollen on the arm) and VACCINATION SITE ERYTHEMA (red area from above the injection site to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information include ice the area down and  cortizone cream.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: clear liquid with a little blood leaked down arm when needle removed; clear liquid with a little blood leaked down arm when needle removed; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed). On 09-Mar-2021, UNDERDOSE (clear liquid with a little blood leaked down arm when needle removed) and DEVICE CONNECTION ISSUE (clear liquid with a little blood leaked down arm when needle removed) had resolved.            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Limb discomfort, Nasopharyngitis, Pain in extremity
Clinical narrative: arm was sore; Arm was heavy; gets cold and can't get warm; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (gets cold and can't get warm), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 16-Feb-2021, the patient experienced NASOPHARYNGITIS (gets cold and can't get warm) and INFLUENZA LIKE ILLNESS (flu like symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy). At the time of the report, NASOPHARYNGITIS (gets cold and can't get warm), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (arm was sore) and LIMB DISCOMFORT (Arm was heavy) outcome was unknown. Unknown          Concomitant product use was not provided by the reporter. Treatment information  was not provided. The action taken with mRNA in response to these events was not applicable.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Cough, Dizziness, Feeling abnormal
Clinical narrative: Left arm is very sore; Nauseous; Coughing; Back pain intensified; Felt bad all day; Fever; Muscles hurt; Joints hurt; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore) and FEELING ABNORMAL (Felt bad all day) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain (She usually has back pain).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy). On 09-Mar-2021, the patient experienced COUGH (Coughing), BACK PAIN (Back pain intensified), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm is very sore) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt), ARTHRALGIA (Joints hurt) and NAUSEA (Nauseous) 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 product use was not provided by the reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Left arm is very sore; Nauseous; Coughing; Back pain intensified; Felt bad all day; Fever; Muscles hurt; Joints hurt; Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore) and FEELING ABNORMAL (Felt bad all day) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back pain (She usually has back pain).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy). On 09-Mar-2021, the patient experienced COUGH (Coughing), BACK PAIN (Back pain intensified), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm is very sore) and NAUSEA (Nauseous). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy), COUGH (Coughing), BACK PAIN (Back pain intensified), PAIN IN EXTREMITY (Left arm is very sore), FEELING ABNORMAL (Felt bad all day), PYREXIA (Fever), MYALGIA (Muscles hurt), ARTHRALGIA (Joints hurt) and NAUSEA (Nauseous) 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 product use was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: couldn't move left leg or foot; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move left leg or foot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A211A) for COVID-19 vaccination.     The patient's past medical history included Stroke (patient had stroke in 2017). Concomitant products included SIMVASTATIN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 10-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 10-Mar-2021, the patient experienced LIMB DISCOMFORT (couldn't move left leg or foot). At the time of the report, LIMB DISCOMFORT (couldn't move left leg or foot) outcome was unknown.            Treatment drugs were not provided, Action taken with mRNA-1273 in response to the event was not applicable.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Area near injection site had lumps (it was initially 2, but it got bigger and become one); Area near injection site was itchy; Area near injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Area near injection site had lumps (it was initially 2, but it got bigger and become one)), VACCINATION SITE PRURITUS (Area near injection site was itchy) and VACCINATION SITE ERYTHEMA (Area near injection site was red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE MASS (Area near injection site had lumps (it was initially 2, but it got bigger and become one)), VACCINATION SITE PRURITUS (Area near injection site was itchy) and VACCINATION SITE ERYTHEMA (Area near injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Area near injection site had lumps (it was initially 2, but it got bigger and become one)), VACCINATION SITE PRURITUS (Area near injection site was itchy) and VACCINATION SITE ERYTHEMA (Area near injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore Throat; Cough; Weakness; body aches; Fever; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), COUGH (Cough), ASTHENIA (Weakness), MYALGIA (body aches) and PYREXIA (Fever) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), COUGH (Cough), ASTHENIA (Weakness), MYALGIA (body aches) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), COUGH (Cough), ASTHENIA (Weakness), MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Lethargy, Myalgia, Pyrexia
Clinical narrative: Fever around 100 degrees; Body aches; Chills.; Still feel more lethargic at night; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported).    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night). At the time of the report, PYREXIA (Fever around 100 degrees), MYALGIA (Body aches), CHILLS (Chills.) and LETHARGY (Still feel more lethargic at night) outcome was unknown. Not Provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling cold, Headache, Myalgia
Clinical narrative: skin was hot; feeling really cold; Little nauseated; Headache/felt pounding behind head and temple; muscle pain was unbearable; arm got real heavy and painful; pretty dizzy; pretty weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (pretty dizzy), ASTHENIA (pretty weak), PAIN IN EXTREMITY (arm got real heavy and painful), SKIN WARM (skin was hot) and FEELING COLD (feeling really cold) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (pretty dizzy) and ASTHENIA (pretty weak). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm got real heavy and painful). On an unknown date, the patient experienced SKIN WARM (skin was hot), FEELING COLD (feeling really cold), NAUSEA (Little nauseated), HEADACHE (Headache/felt pounding behind head and temple) and MYALGIA (muscle pain was unbearable). At the time of the report, DIZZINESS (pretty dizzy), ASTHENIA (pretty weak), PAIN IN EXTREMITY (arm got real heavy and painful), SKIN WARM (skin was hot), FEELING COLD (feeling really cold), NAUSEA (Little nauseated), HEADACHE (Headache/felt pounding behind head and temple) and MYALGIA (muscle pain was unbearable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Skin warm
Clinical narrative: skin was hot; feeling really cold; Little nauseated; Headache/felt pounding behind head and temple; muscle pain was unbearable; arm got real heavy and painful; pretty dizzy; pretty weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (pretty dizzy), ASTHENIA (pretty weak), PAIN IN EXTREMITY (arm got real heavy and painful), SKIN WARM (skin was hot) and FEELING COLD (feeling really cold) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (pretty dizzy) and ASTHENIA (pretty weak). On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm got real heavy and painful). On an unknown date, the patient experienced SKIN WARM (skin was hot), FEELING COLD (feeling really cold), NAUSEA (Little nauseated), HEADACHE (Headache/felt pounding behind head and temple) and MYALGIA (muscle pain was unbearable). At the time of the report, DIZZINESS (pretty dizzy), ASTHENIA (pretty weak), PAIN IN EXTREMITY (arm got real heavy and painful), SKIN WARM (skin was hot), FEELING COLD (feeling really cold), NAUSEA (Little nauseated), HEADACHE (Headache/felt pounding behind head and temple) and MYALGIA (muscle pain was unbearable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: pounding headache; chills; high fever; She also got vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (pounding headache), CHILLS (chills), PYREXIA (high fever) and VOMITING (She also got vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm soon after vaccine for one day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm soon after vaccine for one day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm soon after vaccine for one day). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 10-Mar-2021, VACCINATION SITE PAIN (sore arm soon after vaccine for one day) had resolved.            Concomitant product use was not provided by the reporter.  the patient administered with the second dose of vaccine she didn't experienced with sore arm and felt great.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up information received on 21-JUN-2021 contains  non significant and no new information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Injection site is red, itchy, and hot to touch; Injection site is red, itchy, and hot to touch; Injection site is red, itchy, and hot to touch; Rash near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Consumer is allergic to penicillin products.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site is red, itchy, and hot to touch), VACCINATION SITE PRURITUS (Injection site is red, itchy, and hot to touch), VACCINATION SITE ERYTHEMA (Injection site is red, itchy, and hot to touch) and VACCINATION SITE RASH (Rash near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included oral allergy medicine (unspecified).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye pain, Migraine, Vomiting
Clinical narrative: Migraine; RIGHT EYE HURTING LIKE SOMEONE HIM WITH PEPPER SPRAY; VOMITING; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), EYE PAIN (RIGHT EYE HURTING LIKE SOMEONE HIM WITH PEPPER SPRAY) and VOMITING (VOMITING) in an 18-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 05-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 MIGRAINE (Migraine), EYE PAIN (RIGHT EYE HURTING LIKE SOMEONE HIM WITH PEPPER SPRAY) and VOMITING (VOMITING). At the time of the report, MIGRAINE (Migraine), EYE PAIN (RIGHT EYE HURTING LIKE SOMEONE HIM WITH PEPPER SPRAY) and VOMITING (VOMITING) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications are provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: TCR received on 21-Jun-2021 and contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Product packaging quantity issue
Clinical narrative: vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) 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 09-Mar-2021, the patient experienced PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose). On 09-Mar-2021, PRODUCT PACKAGING QUANTITY ISSUE (vial was used to vaccinate 9 patients and the 10th dose was not used to vaccinate a patient because it was not a complete dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was reported.  The nurse reported that she drew only 9 doses out of a vial and the 10th dose was only 0.2ml instead of 0.5ml. She received the shipment on 18Feb2021 and has already dispense 80 of the 100 vials. Only this one vial has had this problem so far. She just called to report it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling at injection site; Hot and sore at injection site; Redness at injection site; Hot and sore at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE WARMTH (Hot and sore at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Hot and sore at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE WARMTH (Hot and sore at injection site) and VACCINATION SITE PAIN (Hot and sore at injection site). 19-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE WARMTH (Hot and sore at injection site) and VACCINATION SITE PAIN (Hot and sore at injection site) had resolved and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No treatment details and concomitant medications are reported..  The patient developed swelling, redness and hotness at injection site on 19-Feb-2021, which remained for 3 days. Then it automatically subsided. Then one week after that it came again, redness and soreness. and it subsided after  two or three days. and nowagain there is redness at the injection site.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: 3 shots of vaccine; A spontaneous report was received from a nurse concerning a female patient of unknown age, who received an extra dose of Moderna's COVID-19 vaccine (mRNA-1273) .  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 09-mar-2021, the patient received the dose of mRNA-1273 (Lot number: 014M20A) for prophylaxis of COVID-19 infection. The patient was given with 3 shots of vaccine mistakenly/Extra dose administered.    Treatment details for events was not provided  Action taken with mRNA-1273 in response to the events was not applicable.   The  outcome of the events, extra dose received/3 shots of vaccine was considered to be recovered.; Reporter's Comments: This report refers to a case of extra dose administered for mRNA-1273, lot # 014M20A  with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Illness, Pain
Clinical narrative: queasy stomach; fever; body aches; runs; sick as a dog; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (queasy stomach), PYREXIA (fever) and PAIN (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AZ1A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-1949, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ILLNESS (sick as a dog), FATIGUE (fatigue), PYREXIA (fever), PAIN (body aches) and DIARRHOEA (runs). On 08-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (queasy stomach). On 01-Mar-2021, ILLNESS (sick as a dog), PYREXIA (fever), PAIN (body aches) and DIARRHOEA (runs) had resolved. At the time of the report, FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach) 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 details included Tylenol, Ginger, Hydrocortisone gel.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: queasy stomach; fever; body aches; runs; sick as a dog; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (queasy stomach), PYREXIA (fever) and PAIN (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011AZ1A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-1949, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ILLNESS (sick as a dog), FATIGUE (fatigue), PYREXIA (fever), PAIN (body aches) and DIARRHOEA (runs). On 08-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (queasy stomach). On 01-Mar-2021, ILLNESS (sick as a dog), PYREXIA (fever), PAIN (body aches) and DIARRHOEA (runs) had resolved. At the time of the report, FATIGUE (fatigue) and ABDOMINAL DISCOMFORT (queasy stomach) 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 details included Tylenol, Ginger, Hydrocortisone gel.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rash
Clinical narrative: Inflammation all over his body; Rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Inflammation all over his body) and RASH (Rash all over his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used included Statin.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (Patient stated that on the 16th of Feb he had a tetanus injection.) on 16-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 10-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in his arm) and PYREXIA (Fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.5 degree f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. No relavant concomitant medications reported. No treatment information was provided. Action taken with mRNA-123 is not applicable. Reporter did not allow further contact.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Ongoing tendonitis or bruise "like" pain at injection site/dull burning pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ongoing tendonitis or bruise "like" pain at injection site/dull burning pain in injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Ongoing tendonitis or bruise "like" pain at injection site/dull burning pain in injection site). At the time of the report, VACCINATION SITE PAIN (Ongoing tendonitis or bruise "like" pain at injection site/dull burning pain in injection site) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Ona n unspecified date the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) in right arm with no issues.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional included second dose information.