chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue pruritus
Clinical narrative: Tongue burns; Tongue swollen; Tongue itches; Lips burns; Lips swollen; Lips itches; Tongue tingling; Lips tingling; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns) and LIP SWELLING (Lips swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns), LIP SWELLING (Lips swollen), LIP PRURITUS (Lips itches), TONGUE DISCOMFORT (Tongue tingling) and ORAL DISCOMFORT (Lips tingling). At the time of the report, TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns), LIP SWELLING (Lips swollen), LIP PRURITUS (Lips itches), TONGUE DISCOMFORT (Tongue tingling) and ORAL DISCOMFORT (Lips tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was provided as diphenhydramine hydrochloride.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary gland enlargement, Swelling face, Throat tightness
Clinical narrative: within 25 minutes of shot, his throat was tightening up; swelling along jawline on both side of his face; salivary gland was swollen and very sensitive; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive). On 03-Feb-2021, THROAT TIGHTNESS (within 25 minutes of shot, his throat was tightening up), SWELLING FACE (swelling along jawline on both side of his face) and SALIVARY GLAND ENLARGEMENT (salivary gland was swollen and very sensitive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Left knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Left knee pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (Left knee pain). At the time of the report, ARTHRALGIA (Left knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fevers; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fevers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) high fevers.  Treatment details included Tylenol and Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.  On 1 Mar 2021 the outcome of event(s), high fevers was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mass, Vaccination site erythema, Vaccination site induration
Clinical narrative: Lump on arm; CHILLS; fatigue; Red, hard itchy arm; Red, hard itchy arm; Red, hard itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm) and VACCINATION SITE INDURATION (Red, hard itchy arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm). At the time of the report, MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Lump on arm; CHILLS; fatigue; Red, hard itchy arm; Red, hard itchy arm; Red, hard itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm) and VACCINATION SITE INDURATION (Red, hard itchy arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-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 MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm). At the time of the report, MASS (Lump on arm), CHILLS (CHILLS), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red, hard itchy arm), VACCINATION SITE INDURATION (Red, hard itchy arm) and VACCINATION SITE PRURITUS (Red, hard itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: Received the second dose of the vaccine by SubQ injection instead of IM; Sore arm; A spontaneous report was received from a 72 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported received the second dose of the vaccine by SubQ injection instead of IM and developed sore arm.  The patient's medical history and concomitant medications were not provided.  On 21-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (batch number: 032L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 01-MAR-2021, the patient received her second of two planned doses of mRNA-1273 (batch number: 014M20A) subcutaneously for the prophylaxis of COVID-19 infection.  On 01-MAR-2021, the patient received the second dose of vaccine subcutaneously instead of intramuscularly and developed sore arm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of received the second dose of the vaccine by SubQ injection instead of IM was considered resolved and the outcome of sore arm was unknown.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273 (lot# 014M20A). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031572:Crosslinked case: Same reporter/different patient (husband) US-MODERNATX, INC.-MOD-2021-032594:Crosslinked case: Same reporter (Wife case (2nd dose)
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: 30 to 35 mins after the injection he experienced redness and itchiness on the injection site; 30 to 35 mins after the injection he experienced redness and itchiness on the injection site, his; 30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach; 30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on the injection site), INJECTION SITE ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on the injection site, his), PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach) and ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, BENAZEPRIL, AMLODIPINE and METFORMIN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on the injection site), INJECTION SITE ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on the injection site, his), PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach) and ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach). On 02-Mar-2021, INJECTION SITE PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on the injection site), INJECTION SITE ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on the injection site, his), PRURITUS (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach) and ERYTHEMA (30 to 35 mins after the injection he experienced redness and itchiness on his right hand, his neck and stomach) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       consent to follow up with safety YES
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Pyrexia
Clinical narrative: Chills; fever of 100 degrees.; Sore joints; woke up with a 103 degree fever; He also has a little bit of a runny nose; Cough; Felt tired again; Chills; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt a little tired), FATIGUE (Felt tired again) and the first episode of CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (Felt a little tired). On 28-Feb-2021, the patient experienced RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt tired again), the first episode of CHILLS (Chills), PYREXIA (woke up with a 103 degree fever) and ARTHRALGIA (Sore joints). On 01-Mar-2021, the patient experienced the second episode of CHILLS (Chills) and PYREXIA (fever of 100 degrees.). At the time of the report, RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt a little tired), FATIGUE (Felt tired again), the last episode of CHILLS (Chills), PYREXIA (woke up with a 103 degree fever), PYREXIA (fever of 100 degrees.) and ARTHRALGIA (Sore joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Chills; fever of 100 degrees.; Sore joints; woke up with a 103 degree fever; He also has a little bit of a runny nose; Cough; Felt tired again; Chills; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt a little tired), FATIGUE (Felt tired again) and the first episode of CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (Felt a little tired). On 28-Feb-2021, the patient experienced RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt tired again), the first episode of CHILLS (Chills), PYREXIA (woke up with a 103 degree fever) and ARTHRALGIA (Sore joints). On 01-Mar-2021, the patient experienced the second episode of CHILLS (Chills) and PYREXIA (fever of 100 degrees.). At the time of the report, RHINORRHOEA (He also has a little bit of a runny nose), COUGH (Cough), FATIGUE (Felt a little tired), FATIGUE (Felt tired again), the last episode of CHILLS (Chills), PYREXIA (woke up with a 103 degree fever), PYREXIA (fever of 100 degrees.) and ARTHRALGIA (Sore joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching) and URTICARIA (hives) 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 No adverse event.    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 PRURITUS (itching) and URTICARIA (hives). At the time of the report, PRURITUS (itching) and URTICARIA (hives) 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.
Age: 75.0
Sex: F
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 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Dizziness; Weakness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 09-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea). On 10-Feb-2021, DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red; Swelling arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red) and PERIPHERAL SWELLING (Swelling arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red) and PERIPHERAL SWELLING (Swelling arm). At the time of the report, ERYTHEMA (Red) and PERIPHERAL SWELLING (Swelling arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications use were not reported No treatment information were reported.  .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Leakage during administration, half of the vaccine leaked out; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out). On 22-Feb-2021, UNDERDOSE (Leakage during administration, half of the vaccine leaked out) and DEVICE CONNECTION ISSUE (Leakage during administration, half of the vaccine leaked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly,patient did not experience any adverse reactions to vaccine given. Moderna dose that was given on 22-Feb-2021 leaked out during administration. Nurse that gave the vaccine stated that about half the dose of vaccine leaked out.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Information added to the narrative.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273, lot # 024M20A, with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: headache; body aches; fever; chills; nausea; swelling; redness at injection site; hardness; muscle aches; A spontaneous report was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: headache; body aches; fever; chills; nausea; swelling; redness at injection site; hardness; muscle aches; A spontaneous report was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Somnolence, Vomiting
Clinical narrative: throw up again; Sore in arm; Feeling lightheaded; slept most of the time; Throw up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded), SOMNOLENCE (slept most of the time), VOMITING (Throw up) and VOMITING (throw up again) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 032M20A) for COVID-19 vaccination.     No Medical History reported by reporter.  Concomitant products included CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULPHATE) from 26-Apr-2020 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN 81), LOSARTAN, ATORVASTATIN and TICAGRELOR (BRILINTA) from 15-Apr-2019 to 01-Apr-2020 for an unknown indication.   On 17-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded) and SOMNOLENCE (slept most of the time). 17-Feb-2021, the patient experienced VOMITING (Throw up). On 02-Mar-2021, the patient experienced VOMITING (throw up again). On 18-Feb-2021, PAIN IN EXTREMITY (Sore in arm), DIZZINESS (Feeling lightheaded), SOMNOLENCE (slept most of the time) and VOMITING (Throw up) had resolved. At the time of the report, VOMITING (throw up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Additional information provided:VAERS form-Concomitant medications, Dose 2 details ,New events and details of events added
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: slept the entire day; Fever 100.4; fatigue; chills; Diarrhea; Projectile Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea), VOMITING (Projectile Vomiting), FATIGUE (fatigue) and PYREXIA (Fever 100.4) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur), Drug allergy (Codiene), Blood pressure high since 01-Dec-2000, Dementia since 01-Dec-2020 and Cholesterol (NOS). Concomitant products included DESLORATADINE for Allergy, ROSUVASTATIN for Cholesterol, DONEPEZIL HCL and MEMANTINE HYDROCHLORIDE for Dementia.    On 24-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 28-Feb-2021, the patient experienced FATIGUE (fatigue). On 01-Mar-2021, the patient experienced PYREXIA (Fever 100.4). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 15-Mar-2021, FATIGUE (fatigue), PYREXIA (Fever 100.4) and CHILLS (chills) had resolved. At the time of the report, SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 100.4 (High) Fever 100.4. On an unknown date, Blood pressure measurement: 156/82 (High) blood pressure was at 156/82 and 160/79 (High) the second time 160/79. On an unknown date, Heart rate: 93 (High) 93 pulse rate and 92 (High) 92 pulse rate. On an unknown date, Oxygen saturation: 95 percent (normal) oxygen level was at 95%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       48 hours following the first dose administration of mRNA-1273 the patient experienced projectile vomiting and diarrhea, which lasted for 2-3 days as well as extreme fatigue that lasted for 7 - 10days. Lower level fatigue continued for an additional 14 days with all symptoms resolved by 15-Mar-2021.  At the time of the report the follow-up report received on 24-Jun-2021, the patient's caregiver's decided not to have the patient receive the second dose due to concerns over how her body might handle it.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow-up - Patient demographics, relevant history, concomitant products, vaccine facility details, new event ''Diarrhea'' added and narrative updated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation, Pyrexia, Somnolence, Vomiting
Clinical narrative: slept the entire day; Fever 100.4; fatigue; chills; Diarrhea; Projectile Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea), VOMITING (Projectile Vomiting), FATIGUE (fatigue) and PYREXIA (Fever 100.4) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur), Drug allergy (Codiene), Blood pressure high since 01-Dec-2000, Dementia since 01-Dec-2020 and Cholesterol (NOS). Concomitant products included DESLORATADINE for Allergy, ROSUVASTATIN for Cholesterol, DONEPEZIL HCL and MEMANTINE HYDROCHLORIDE for Dementia.    On 24-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 28-Feb-2021, the patient experienced FATIGUE (fatigue). On 01-Mar-2021, the patient experienced PYREXIA (Fever 100.4). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 15-Mar-2021, FATIGUE (fatigue), PYREXIA (Fever 100.4) and CHILLS (chills) had resolved. At the time of the report, SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 100.4 (High) Fever 100.4. On an unknown date, Blood pressure measurement: 156/82 (High) blood pressure was at 156/82 and 160/79 (High) the second time 160/79. On an unknown date, Heart rate: 93 (High) 93 pulse rate and 92 (High) 92 pulse rate. On an unknown date, Oxygen saturation: 95 percent (normal) oxygen level was at 95%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       48 hours following the first dose administration of mRNA-1273 the patient experienced projectile vomiting and diarrhea, which lasted for 2-3 days as well as extreme fatigue that lasted for 7 - 10days. Lower level fatigue continued for an additional 14 days with all symptoms resolved by 15-Mar-2021.  At the time of the report the follow-up report received on 24-Jun-2021, the patient's caregiver's decided not to have the patient receive the second dose due to concerns over how her body might handle it.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow-up - Patient demographics, relevant history, concomitant products, vaccine facility details, new event ''Diarrhea'' added and narrative updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: fever and chills again; Chills; Fatigue; nausea; ache all over the body; fever; chills; feels "very very tired"; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired"). On 01-Mar-2021, the patient experienced PYREXIA (fever and chills again), CHILLS (Chills) and FATIGUE (Fatigue). On 28-Feb-2021, NAUSEA (nausea), MYALGIA (ache all over the body), PYREXIA (fever), CHILLS (chills) and FATIGUE (feels "very very tired") had resolved. At the time of the report, PYREXIA (fever and chills again), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Felt like she had the flu; Stayed on bed all day sleeping; Fatigue; Headache; Chills; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to the flu shot, NSAIDS) and Allergy (allergic to some chicken).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt like she had the flu; Stayed on bed all day sleeping; Fatigue; Headache; Chills; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to the flu shot, NSAIDS) and Allergy (allergic to some chicken).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like she had the flu), SOMNOLENCE (Stayed on bed all day sleeping), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Muscle Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 100.5°F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (100.5°F fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (100.5°F fever). At the time of the report, PYREXIA (100.5°F fever) had resolved.            No Concomitant Medication was provided by the reporter. No treatment  was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30 Apr 2021: Updated event outcome
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 after first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after first dose of vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after first dose of vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after first dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient used putting ice on the arm and that seemed to help.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Mild 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Mild reaction). At the time of the report, UNEVALUABLE EVENT (Mild reaction) had resolved.            No concomitant medication   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Outcome of event updated from unknown to resolved and patient declined further follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Pruritus, Skin discolouration
Clinical narrative: Pink and "a little itchy" area; Pink and "a little itchy" area; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Pink and "a little itchy" area) and PRURITUS (Pink and "a little itchy" area) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced SKIN DISCOLOURATION (Pink and "a little itchy" area) and PRURITUS (Pink and "a little itchy" area). At the time of the report, SKIN DISCOLOURATION (Pink and "a little itchy" area) and PRURITUS (Pink and "a little itchy" area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Biopsy skin: (Negative) Negative.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Vaccination site erythema
Clinical narrative: Flu like symptoms; Nausea; Mild Headache; Big red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Big red circle on arm), NAUSEA (Nausea) and HEADACHE (Mild Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle on arm). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), NAUSEA (Nausea) and HEADACHE (Mild Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Big red circle on arm), NAUSEA (Nausea) and HEADACHE (Mild Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had unspecified thyroid medication as concomitant medications.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Dry cough; sneezing; soreness; muscle aches and pain; low grade fever; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas). At the time of the report, COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter. The patient mentioned she would not be preferred to be contacted as there are no more side effects and she was dealing with more serious problem.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Dry cough; sneezing; soreness; muscle aches and pain; low grade fever; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas). At the time of the report, COUGH (Dry cough), PAIN (soreness), MYALGIA (muscle aches and pain), PYREXIA (low grade fever) and NAUSEA (Nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter. The patient mentioned she would not be preferred to be contacted as there are no more side effects and she was dealing with more serious problem.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains non-significant information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paronychia
Clinical narrative: Infection on the finger; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events infection on the finger.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Infection on the finger.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), infection on the finger was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site haemorrhage
Clinical narrative: blood under the bandage.; sore arm; A spontaneous report was received from a consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, blood underneath bandage.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 1 Mar 2021, the patient experienced the event(s) sore arm, blood underneath bandage.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, blood underneath bandage was unknown.