chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination complication
Clinical narrative: everything that you folk list for side effects I basically had; No Appetite; sick; Almost felt nauseous/wanting to vomit; had fatigue; Fever; Chills; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (everything that you folk list for side effects I basically had), DECREASED APPETITE (No Appetite), ILLNESS (sick), NAUSEA (Almost felt nauseous/wanting to vomit) and FATIGUE (had fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 012L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced VACCINATION COMPLICATION (everything that you folk list for side effects I basically had), DECREASED APPETITE (No Appetite), NAUSEA (Almost felt nauseous/wanting to vomit), FATIGUE (had fatigue), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). 05-Nov-2021, the patient experienced ILLNESS (sick). On 06-Nov-2021, VACCINATION COMPLICATION (everything that you folk list for side effects I basically had), DECREASED APPETITE (No Appetite), ILLNESS (sick), NAUSEA (Almost felt nauseous/wanting to vomit), FATIGUE (had fatigue), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-378218 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection; This spontaneous case was reported by a physician and describes the occurrence of VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer. Concomitant products included OMEPRAZOLE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection). At the time of the report, VIRAL INFECTION (Patient developed some virus,3 weeks after receiving the vaccine the patient got the infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in her mid 40's and was healthy.  Concomitant medication included med infusion and cancer treatment. No treatment medication was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: received 3rd full dose; chills; fatigue/he stated he is "almost back to par", but still is experiencing fatigue; feeling achy; sore right arm/ some soreness still in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received 3rd full dose), CHILLS (chills), FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue), MYALGIA (feeling achy) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to sulfa) and Penicillin allergy. Concomitant products included LOSARTAN, ATORVASTATIN and HYDROCHLOROTHIAZIDE (HCTZ) for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 3rd full dose) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm). 05-Nov-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue) and MYALGIA (feeling achy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Nov-2021, ACCIDENTAL OVERDOSE (received 3rd full dose) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (feeling achy) was resolving and FATIGUE (fatigue/he stated he is "almost back to par", but still is experiencing fatigue) and VACCINATION SITE PAIN (sore right arm/ some soreness still in the right arm) had not resolved.            He stated events got worse on 06-Nov-2021.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Prostatitis
Clinical narrative: prostatitis/prostatitis spread throughout his body in an infection; left shoulder was still hurting; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) (seriousness criterion hospitalization) and ARTHRALGIA (left shoulder was still hurting). At the time of the report, PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) and ARTHRALGIA (left shoulder was still hurting) had not resolved.            No concomitant and treatment information was provided. It was reported that the patient's left shoulder was still hurting since he got the second shot. Patient ended up 2 weeks later getting prostatitis and never went away. Patient ended up in hospital. It came back and got spread throughout his body in an infection which was still present.  Company Comment: This case concerns a 60-year-old, male patient, with no known medical history, who experienced the serious, unexpected event of prostatitis and non-serious expected event of arthralgia. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is event prostatitis is still on going. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old, male patient, with no known medical history, who experienced the serious, unexpected event of prostatitis and non-serious expected event of arthralgia. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is event prostatitis is still on going. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Illness, Influenza like illness, Vomiting
Clinical narrative: flu-like symptoms; Dizziness; Diarrhea; very sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03F2117, 026L20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting) had not resolved.            Concomitant medication included unspecified stomach medicine. Treatment medication included cold and flu medicine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL; the doctor stated that the patient was not immunocompromised.; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, the patient experienced OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.). On 04-Nov-2021, OVERDOSE (Patient received 3rd dose instead of booster dose/Was administered a 3rd dose (0.5mL dose) to the patient instead of a booster dose of 0.25mL) and OFF LABEL USE (the doctor stated that the patient was not immunocompromised.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was administered a 3rd dose (0.5mL dose) instead of a booster dose (0.25 mL). The pharmacist stated that, the doctor stated that the patient was not immunocompromised.  The pharmacist stated that the patient had late stage Alzheimer's. The pharmacist stated that the vaccine was administered to the patient at their house by the pharmacy.   No concomitant medications or treatment details were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Tips of feet upto ankle burning very intensly after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported by reporter.  Concomitant products included ATORVASTATIN for Cholesterol, OXYCODONE for Pain, AMLODIPINE for Tachycardia.    On 13-Feb-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 BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot). At the time of the report, BURNING SENSATION (Tips of feet upto ankle burning very intensly after 1st shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications include unspecified Prostate medication and unspecified Androgens. Treatment information was not provided.   This case was linked to MOD-2021-318478 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: all 3 individuals had a sore arm; 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 PAIN IN EXTREMITY (all 3 individuals had a sore arm) 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 PAIN IN EXTREMITY (all 3 individuals had a sore arm). At the time of the report, PAIN IN EXTREMITY (all 3 individuals had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that all three different physical therapists had a sore arm after vaccine.  Concomitant medications were not reported. Treatment information was reported as unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown.            Concomitant medications detail were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Non-Significant Follow up received on 08/Nov/2021-Document attached
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: discomfort in his arm after doses 1 and 2; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) 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 Stroke (she said "derrame") in 2016.    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 DISCOMFORT (discomfort in his arm after doses 1 and 2). At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in his arm after doses 1 and 2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-378284, MOD-2021-378302 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: Brain Zaps; This spontaneous case was reported by a patient and describes the occurrence of ELECTRIC SHOCK SENSATION (Brain Zaps) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ELECTRIC SHOCK SENSATION (Brain Zaps). At the time of the report, ELECTRIC SHOCK SENSATION (Brain Zaps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch; little itchy; it is swollen; reddish; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen), VACCINATION SITE ERYTHEMA (reddish) and FATIGUE (feeling tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 012M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced FATIGUE (feeling tired). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen) and VACCINATION SITE ERYTHEMA (reddish). The patient was treated with Manual therapy (Applied ice pack) for Vaccination site warmth; Manual therapy (Applied ice pack) for Vaccination site pruritus; Manual therapy (Applied ice pack) for Vaccination site swelling; Manual therapy (Applied ice pack) for Vaccination site erythema and Manual therapy (Applied ice pack) for Fatigue. On 05-Nov-2021, FATIGUE (feeling tired) had resolved. On 07-Nov-2021, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (little itchy), VACCINATION SITE SWELLING (it is swollen) and VACCINATION SITE ERYTHEMA (reddish) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-378334, MOD-2021-378309 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Erythema, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: They are so stiff; Trigger finger; legs were aching / hands were predominantly worse / hand pain; Joint pain in legs and hands; Felt off; And was red in a large area; Arm was sore; Had a raised area; Feverish / fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain), VACCINATION COMPLICATION (Felt off) and ERYTHEMA (And was red in a large area) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area) and PYREXIA (Feverish / fever of 101.4). On 06-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) and ARTHRALGIA (Joint pain in legs and hands). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area), PYREXIA (Feverish / fever of 101.4) and ARTHRALGIA (Joint pain in legs and hands) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger) and PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 101.4 (High) 101.4.         Concomitant drugs were not reported. Treatment included hot pads.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Trigger finger, Vaccination complication, Vaccination site swelling
Clinical narrative: They are so stiff; Trigger finger; legs were aching / hands were predominantly worse / hand pain; Joint pain in legs and hands; Felt off; And was red in a large area; Arm was sore; Had a raised area; Feverish / fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain), VACCINATION COMPLICATION (Felt off) and ERYTHEMA (And was red in a large area) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area) and PYREXIA (Feverish / fever of 101.4). On 06-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) and ARTHRALGIA (Joint pain in legs and hands). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area), PYREXIA (Feverish / fever of 101.4) and ARTHRALGIA (Joint pain in legs and hands) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger) and PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 101.4 (High) 101.4.         Concomitant drugs were not reported. Treatment included hot pads.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Lymphadenopathy, Peripheral swelling, Pruritus
Clinical narrative: bad ear pain; itching; swollen spot on the arm; ringing in the ear. swollen gland; ear infection; rash; with fever or 102.6; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.) and LYMPHADENOPATHY (swollen gland) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (over-react to certain medicine). Concomitant products included EPINEPHRINE (EPIPEN) for Drug allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-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 EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6). At the time of the report, EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6) outcome was unknown.            Patient didn't take any treatment medications.  Patient went to the HCP and felt that there was ear infection. Patient believes it was from the vaccine.   This case was linked to MOD-2021-378337 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Tinnitus
Clinical narrative: bad ear pain; itching; swollen spot on the arm; ringing in the ear. swollen gland; ear infection; rash; with fever or 102.6; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.) and LYMPHADENOPATHY (swollen gland) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (over-react to certain medicine). Concomitant products included EPINEPHRINE (EPIPEN) for Drug allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-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 EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6). At the time of the report, EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6) outcome was unknown.            Patient didn't take any treatment medications.  Patient went to the HCP and felt that there was ear infection. Patient believes it was from the vaccine.   This case was linked to MOD-2021-378337 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 032L20A and 042L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (5 Weeks before booster vaccine on left arm).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.            No treatment information was provided. No concomitant medication was provided. Patient repoted that covid arm started around the area of the injection and moved down all the way for the shoulder to almost his left elbow joint.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 030M20A) 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) (unknown route) 1 dosage form. On 17-Mar-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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No concomitant and treatment medication reported.   This case was linked to MOD-2021-378416 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck mass, Vaccination site lymphadenopathy, Vaccination site rash
Clinical narrative: Lymph nodes inflamed; felt fatigued; Big rash; Lumps/lumps under the neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lumps/lumps under the neck), FATIGUE (felt fatigued), VACCINATION SITE RASH (Big rash) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] and POTASSIUM for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NECK MASS (Lumps/lumps under the neck) and VACCINATION SITE RASH (Big rash). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt fatigued). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, NECK MASS (Lumps/lumps under the neck), FATIGUE (felt fatigued), VACCINATION SITE RASH (Big rash) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes inflamed) outcome was unknown.            This case was linked to MOD-2021-378325 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore left arm after the third full dose; Tired after the third full dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 002B21A and 01120A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose). At the time of the report, PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.   This case was linked to MOD-2021-379340 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: No new information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Feeling of lightheadedness/Dizzziness; Loud tinnitus; Sensitivity to lights; Limited ability to live; Walking is very unpleasant; Vestibular system compromised; Feels brain is floating off-balance inside my skull; Difficulty to focus on anything for any length of time; cant drive more than 20 minutes; Anxiety; Life altering and debilitating; Fatigue; Headaches; Violent vertigo; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VERTIGO (Violent vertigo) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches). In May 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches) had not resolved.            Concomitant product information and treatment information was not reported. Patient had a worst random vertigo episodes
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Headache, Impaired driving ability, Influenza like illness
Clinical narrative: Feeling of lightheadedness/Dizzziness; Loud tinnitus; Sensitivity to lights; Limited ability to live; Walking is very unpleasant; Vestibular system compromised; Feels brain is floating off-balance inside my skull; Difficulty to focus on anything for any length of time; cant drive more than 20 minutes; Anxiety; Life altering and debilitating; Fatigue; Headaches; Violent vertigo; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VERTIGO (Violent vertigo) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches). In May 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches) had not resolved.            Concomitant product information and treatment information was not reported. Patient had a worst random vertigo episodes
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Photophobia, Tinnitus, Vertigo, Vestibular disorder
Clinical narrative: Feeling of lightheadedness/Dizzziness; Loud tinnitus; Sensitivity to lights; Limited ability to live; Walking is very unpleasant; Vestibular system compromised; Feels brain is floating off-balance inside my skull; Difficulty to focus on anything for any length of time; cant drive more than 20 minutes; Anxiety; Life altering and debilitating; Fatigue; Headaches; Violent vertigo; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VERTIGO (Violent vertigo) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches). In May 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches) had not resolved.            Concomitant product information and treatment information was not reported. Patient had a worst random vertigo episodes
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm was sore at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-378927 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (artificial heart valve).   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (I felt tired). At the time of the report, FATIGUE (I felt tired) outcome was unknown.            It was reported that, the patient did not have her vaccination card with her and it was at home. She also stated , she had an artificial heart valve and her cardiologist wants her to have the booster dose.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-378196 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Product storage error; Poor quality product administered; 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 PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On 25-Jun-2021, PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The temperature log had a date when the refrigerator reached 34 and 32 degrees F.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Petechia, Ecchymosis and immune thrombocytopenia; This literature-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concurrent medical conditions included Immune thrombocytopenia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Petechia, Ecchymosis and immune thrombocytopenia) to be possibly related.    Concomitant medications were not reported Treatment medications were not reported.  Company Comment: This case concerns a 34-year-old male patient with a relevant medical history of Immune thrombocytopenia, who experienced the unexpected serious event/AESI of Immune thrombocytopenia aggravated after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the dose of mRNA- 1273 vaccine, dose number unknown. Clinical manifestations included petechiae and ecchymoses. The rechallenge is not applicable since only information about the first dose was disclosed. Underlying immune thrombocytopenia remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report; Sender's Comments: This case concerns a 34-year-old male patient with a relevant medical history of Immune thrombocytopenia, who experienced the unexpected serious event/AESI of Immune thrombocytopenia aggravated after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax). The event occurred approximately 3 days after the dose of mRNA- 1273 vaccine, dose number unknown. Clinical manifestations included petechiae and ecchymoses. The rechallenge is not applicable since only information about the first dose was disclosed. Underlying immune thrombocytopenia remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report