chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Symptoms got much worse after the 2nd shot; Bone pain; Difficulty breathing / Shortness of breath; Difficulty focusing; Fogginess; Absolute exhaustion; Horrible chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath) and FEELING ABNORMAL (Fogginess) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE, ATENOLOL, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot). At the time of the report, PYREXIA (Fever), CHILLS (Horrible chills), BONE PAIN (Bone pain), DYSPNOEA (Difficulty breathing / Shortness of breath), FEELING ABNORMAL (Fogginess), DISTURBANCE IN ATTENTION (Difficulty focusing), FATIGUE (Absolute exhaustion) and CONDITION AGGRAVATED (Symptoms got much worse after the 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-239302 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Tingling in hand and feet; Hard time catching breath; Extreme pain in body; Not able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed). At the time of the report, PARAESTHESIA (Tingling in hand and feet), DYSPNOEA (Hard time catching breath), PAIN (Extreme pain in body) and MOBILITY DECREASED (Not able to get out of bed) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-074867 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient experienced: COVID on 29-May-2021 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included GERD, Ear infection (Increase frequency), Calcium deficiency and Tympanostomy tube insertion. Concurrent medical conditions included Osteoporosis, Irritable bowel syndrome and Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), ZOLEDRONIC ACID (RECLAST), PROBIOTICS NOS, CALCIUM CARBONATE, CETIRIZINE HYDROCHLORIDE (CETRIZINE), CYANOCOBALAMINE, MAGNESIUM, SUCRALFATE, VITAMIN B COMPLEX, VITAMIN D NOS, GLUTAMINE [LEVOGLUTAMIDE] and ALGELDRATE, SODIUM ALGINATE (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination). At the time of the report, COVID-19 (patient experienced: COVID on 29-May-2021 after vaccination) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also includes pumpkin seed extract soy germ.  Patient's past medical history also includes reproductive issues.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 15 yo received Moderna Vx; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (15 yo received Moderna Vx) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.  List of concomitant medication were not given.   This case was linked to MOD-2021-163988 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 antibody test
Clinical narrative: Simple spasms on shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Simple spasms on shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (Surgery done 10 years ago.). Concurrent medical conditions included Diabetes and Blood pressure. Concomitant products included INSULIN and METFORMIN for Diabetes mellitus.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Simple spasms on shoulder). At the time of the report, MUSCLE SPASMS (Simple spasms on shoulder) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 antibody test: very little (Low) Result was very little.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products included immunosuppressive drugs, novastic for blood pressure and cholesterol medication.  Treatment information was not provided.   This case was linked to MOD-2021-239400 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product expiration date issue, Product label issue
Clinical narrative: labeling error; 30 people received a dose after the 30 day expiry; The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021), PRODUCT LABEL ISSUE (labeling error) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (labeling error). On 30-May-2021, PRODUCT EXPIRATION DATE ISSUE (The last day to use the vials was 26-May-2021, but the expiry date on the vial was written as the 30-May-2021) and EXPIRED PRODUCT ADMINISTERED (30 people received a dose after the 30 day expiry) had resolved. At the time of the report, PRODUCT LABEL ISSUE (labeling error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  On 26 Apr 2021, the reporter received a shipment of the Moderna COVID-19 Vaccine. The vials were kept in the fridge and a daily log of the temperature was carried out. The vials were kept between the recommended 2-8C. The last day to use the vials was 26 May 2021 however there was a labeling error and the expiry date on the vial was written as the 30 May 2021. On 30 May 2021, 30 people received the expired vaccine. 2-3 people received the vaccine as their  1st dose and the others received the vaccine as a 2nd dose.   It was reported that no patients that received the vaccine beyond the 30 day expiry, have called to report side effects.  No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, SARS-CoV-2 antibody test
Clinical narrative: Simple spasms on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Simple spasms on shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (surgery done 10 years ago). Concomitant products included INSULIN and METFORMIN for Diabetes.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-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 MUSCLE SPASMS (Simple spasms on shoulder). At the time of the report, MUSCLE SPASMS (Simple spasms on shoulder) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 antibody test: very little (Low) Result was very little.         Other concomitant medications such as immunosuppressive drugs, Novastic for blood pressure, and an unnamed cholesterol medication.  No treatment information was given by the reporter.   This case was linked to MOD-2021-239394 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Flu like symptoms; Low fever; soreness at the injection arm; swollenness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and PYREXIA (Low fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6381C20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hypothyroidism and Radical nephrectomy (One kidney removed). Concomitant products included SERTRALINE for Anxious depression, EVOLOCUMAB (REPATHA) for High cholesterol, AMLODIPINE and RAMIPRIL for Kidney disorder, LEVOTHYROXINE for Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site). On 10-Mar-2021, the patient experienced PYREXIA (Low fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Mar-2021, INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and PYREXIA (Low fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            No treatment medication were provided.   This case was linked to MOD-2021-020272 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea; intense cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping) 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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping). At the time of the report, DIARRHOEA (Diarrhea) and MUSCLE SPASMS (intense cramping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant details provided
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Erythema, Pruritus
Clinical narrative: red and raised blisters on chest; itchy; burning; red and raised blisters on chest; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026BZIA and 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 31-Mar-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 BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest). At the time of the report, BLISTER (red and raised blisters on chest), PRURITUS (itchy), BURNING SENSATION (burning) and ERYTHEMA (red and raised blisters on chest) had resolved.            The concomitant medications blood pressure medications, antidepressant  , sleeping  pills, vitamins, anti-histamines was reported.         .  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received on 26-Jul-2021 contains significant information all adverse events outcome updated to recovered.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: More than 30 days after moving to refeigerator/administered to 4 patients/3 had their second dose while 1 had their first dose; 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 EXPIRED PRODUCT ADMINISTERED (More than 30 days after moving to refeigerator/administered to 4 patients/3 had their second dose while 1 had their first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (More than 30 days after moving to refeigerator/administered to 4 patients/3 had their second dose while 1 had their first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (More than 30 days after moving to refeigerator/administered to 4 patients/3 had their second dose while 1 had their first dose) 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 relevant concomitant medication was reported. No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Ultrasound thyroid
Clinical narrative: Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert; Pain under left arm pit; Pain in left shoulder,Pain in left side collar bone area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area). The patient was treated with PREDNISONE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and TRAMADOL ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (Lymph nodes swelling by left side collar bone area,Lymph nodes swelling under left armpi,Lymph nodes swelling on left shouldert), AXILLARY PAIN (Pain under left arm pit) and ARTHRALGIA (Pain in left shoulder,Pain in left side collar bone area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound thyroid: (abnormal) a 10 x 9 millimeter swollen lymph node was found under her armpit area..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient reported that she has been experiencing pain for approximately 9 weeks.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Night sweats, Pyrexia, Sluggishness
Clinical narrative: no energy during the day; night sweats; sluggish; feverish; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy during the day), NIGHT SWEATS (night sweats), SLUGGISHNESS (sluggish) and PYREXIA (feverish) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM and VITAMIN B COMPLEX for an unknown indication.   On 19-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (no energy during the day), NIGHT SWEATS (night sweats), SLUGGISHNESS (sluggish) and PYREXIA (feverish). At the time of the report, ASTHENIA (no energy during the day), NIGHT SWEATS (night sweats), SLUGGISHNESS (sluggish) and PYREXIA (feverish) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea for 2 weeks; Headache; Nausea for a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for 2 weeks), HEADACHE (Headache) and NAUSEA (Nausea for a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Diabetes and Blood pressure reading high.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 DIARRHOEA (Diarrhea for 2 weeks), HEADACHE (Headache) and NAUSEA (Nausea for a day). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Upset stomach, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea for 2 weeks) and NAUSEA (Nausea for a day) had resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to MOD-2021-037125 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) 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 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-076390 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Body aches; Fatigue; Little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache). On 07-May-2021, MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information for the event was provided.   This case was linked to MOD-2021-239829 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache). On 07-May-2021, MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Little headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information for the event was provided.   This case was linked to MOD-2021-239829 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dizziness postural, Headache, Mobility decreased
Clinical narrative: Muscle and joint pain; so dizzy that she has to sit down because feels like she's going to fall if she remains standing; Muscle and joint pain; Couldn't get out of bed; Upset stomach; Nausea; Horrible headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) in a 48-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 was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle and joint pain), NAUSEA (Nausea), HEADACHE (Horrible headaches) and PYREXIA (Fever). On 28-Jun-2021, the patient experienced DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing). On an unknown date, the patient experienced ARTHRALGIA (Muscle and joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at a dose of 500 milligram every four hours. On 27-Jun-2021, MOBILITY DECREASED (Couldn't get out of bed) and PYREXIA (Fever) had resolved. On 28-Jun-2021, MYALGIA (Muscle and joint pain) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), ARTHRALGIA (Muscle and joint pain), NAUSEA (Nausea) and HEADACHE (Horrible headaches) outcome was unknown.            This case was linked to MOD-2021-239789 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle and joint pain; so dizzy that she has to sit down because feels like she's going to fall if she remains standing; Muscle and joint pain; Couldn't get out of bed; Upset stomach; Nausea; Horrible headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), MYALGIA (Muscle and joint pain) and ARTHRALGIA (Muscle and joint pain) in a 48-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 was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced MOBILITY DECREASED (Couldn't get out of bed), ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (Muscle and joint pain), NAUSEA (Nausea), HEADACHE (Horrible headaches) and PYREXIA (Fever). On 28-Jun-2021, the patient experienced DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing). On an unknown date, the patient experienced ARTHRALGIA (Muscle and joint pain). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at a dose of 500 milligram every four hours. On 27-Jun-2021, MOBILITY DECREASED (Couldn't get out of bed) and PYREXIA (Fever) had resolved. On 28-Jun-2021, MYALGIA (Muscle and joint pain) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS POSTURAL (so dizzy that she has to sit down because feels like she's going to fall if she remains standing), ARTHRALGIA (Muscle and joint pain), NAUSEA (Nausea) and HEADACHE (Horrible headaches) outcome was unknown.            This case was linked to MOD-2021-239789 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: i feel like i have covid all over again since i got my injection; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection) 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 SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection). At the time of the report, SUSPECTED COVID-19 (i feel like i have covid all over again since i got my injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case reported by a patient family member or friend, describes the occurrence of pain in extremity (sore arm) and fatigue (tiredness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038K20A) for COVID-19 immunization. Concurrent medical conditions included cancer (has cancer and is having treatments). On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore arm) and fatigue (tiredness). At the time of the report, pain in extremity (sore arm) and fatigue (tiredness) resolved. Concomitant product information and treatment information not provided. This case linked to MOD-2021-022449 (patient link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Intentional product misuse, Pain
Clinical narrative: Intentional misuse in product use duration; Appetite lost; FELT ACHY; Diarrhea; Upset stomach; Unevaluable event; This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) in a 70-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No concomitant information was provided by the reporter. There was no reported medical history. It was unknown if the patient was enrolled in Covid-19 vaccine trial On 25th June, 2021 the event of stopped Humira for eight weeks to take the Covid-19 vaccine was amended.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Intentional misuse in product use duration; Appetite lost; FELT ACHY; Diarrhea; Upset stomach; Unevaluable event; This spontaneous case was reported by a physician and describes the occurrence of INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Upset stomach) in a 70-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and UNEVALUABLE EVENT (Unevaluable event). At the time of the report, INTENTIONAL PRODUCT MISUSE (Intentional misuse in product use duration), DECREASED APPETITE (Appetite lost), PAIN (FELT ACHY), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No concomitant information was provided by the reporter. There was no reported medical history. It was unknown if the patient was enrolled in Covid-19 vaccine trial On 25th June, 2021 the event of stopped Humira for eight weeks to take the Covid-19 vaccine was amended.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: Arm was so sore/arm hurt for 5 to 6 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LEVOTHYROXINE, OMEPRAZOLE and TRAMADOL for an unknown indication.    On 15-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 PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days). At the time of the report, PAIN IN EXTREMITY (Arm was so sore/arm hurt for 5 to 6 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) No antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was not provided Patient had two blood tests.Patient said that has no antibodies   This case was linked to MOD-2021-233339 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: soar throat; stomach pain; cold; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (soar throat), ABDOMINAL PAIN UPPER (stomach pain), NASOPHARYNGITIS (cold), HEADACHE (headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (soar throat), ABDOMINAL PAIN UPPER (stomach pain), NASOPHARYNGITIS (cold), HEADACHE (headache) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (soar throat), ABDOMINAL PAIN UPPER (stomach pain), NASOPHARYNGITIS (cold), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurt when he would raise his arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Hurt when he would raise his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurt when he would raise his arm). At the time of the report, PAIN IN EXTREMITY (Hurt when he would raise his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Hurt when he would raise his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurt when he would raise his arm). At the time of the report, PAIN IN EXTREMITY (Hurt when he would raise his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine outside of 12 hour window/ realized the vial had expired in the 12 hour window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment drugs were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021, Contains Non-significant information. Degree of the Primary Reporter: Pharm D.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first shot) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Jaw disorder, Toothache
Clinical narrative: extreme toothache; jaw pressure; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure). At the time of the report, TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-240150.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) 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 VACCINATION SITE SWELLING (swollen at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, VACCINATION SITE SWELLING (swollen at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on both sides of her face; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both sides of her face) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 RASH (rash on both sides of her face). At the time of the report, RASH (rash on both sides of her face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment drug were not reported.