chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Nausea, Pancreatic enzyme abnormality
Clinical narrative: Acute abdomin pain, felt like she was getting pancreatitis pain again; nausea; miserable; chills; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), NAUSEA (nausea), VACCINATION COMPLICATION (miserable), CHILLS (chills) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatitis. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TELMISARTAN, NITROFURANTOIN, ONDANSETRON, OMEPRAZOLE, AMITRIPTYLINE and PANCRELIPASE (VIOKACE).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), NAUSEA (nausea), VACCINATION COMPLICATION (miserable), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), VACCINATION COMPLICATION (miserable) and CHILLS (chills) outcome was unknown and NAUSEA (nausea) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pancreatic enzyme abnormality: 367 367. On an unknown date, White blood cell count increased: increased mild increase in WBC.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication taken were Levothyroxine,Hydrochlorothiazide, telmisartan, Nitrofurantoin 100mg, Ondansetron, Omeprazole, Amitriptyline 10mg, and Viokace. Treatment medications taken were narcotics for pain and tramadol for the attack.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: Acute abdomin pain, felt like she was getting pancreatitis pain again; nausea; miserable; chills; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), NAUSEA (nausea), VACCINATION COMPLICATION (miserable), CHILLS (chills) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pancreatitis. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, TELMISARTAN, NITROFURANTOIN, ONDANSETRON, OMEPRAZOLE, AMITRIPTYLINE and PANCRELIPASE (VIOKACE).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), NAUSEA (nausea), VACCINATION COMPLICATION (miserable), CHILLS (chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN (Acute abdomin pain, felt like she was getting pancreatitis pain again), VACCINATION COMPLICATION (miserable) and CHILLS (chills) outcome was unknown and NAUSEA (nausea) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pancreatic enzyme abnormality: 367 367. On an unknown date, White blood cell count increased: increased mild increase in WBC.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication taken were Levothyroxine,Hydrochlorothiazide, telmisartan, Nitrofurantoin 100mg, Ondansetron, Omeprazole, Amitriptyline 10mg, and Viokace. Treatment medications taken were narcotics for pain and tramadol for the attack.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Muscle discomfort, Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: Pain and discomfort up to his shoulder and neck; discomfort up to his shoulder; Chest pains; Left side ribcage pains; Achiness and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain and discomfort up to his shoulder and neck), MUSCLE DISCOMFORT (discomfort up to his shoulder), CHEST PAIN (Chest pains), MUSCULOSKELETAL CHEST PAIN (Left side ribcage pains) and PAIN (Achiness and discomfort) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE ( 1ST DOSE) on 26-Jan-2021. Concomitant products included SIMVASTATIN, LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D3 and OMEPRAZOLE for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (Pain and discomfort up to his shoulder and neck), MUSCLE DISCOMFORT (discomfort up to his shoulder), MUSCULOSKELETAL CHEST PAIN (Left side ribcage pains) and PAIN (Achiness and discomfort). 26-Jan-2021, the patient experienced CHEST PAIN (Chest pains). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain and discomfort up to his shoulder and neck), MUSCLE DISCOMFORT (discomfort up to his shoulder), CHEST PAIN (Chest pains), MUSCULOSKELETAL CHEST PAIN (Left side ribcage pains) and PAIN (Achiness and discomfort) had resolved. Not Provided          Patient said that he had all the same side effects with the second dose as well, but the second time he experienced a delayed reaction that was on his back between the T9 and T10 muscle. It has been a very achy discomfort and an uncomfortable misery. He does not know if it is related to the vaccine or not. Safety can follow up with patient.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pyrexia
Clinical narrative: Experienced flu like symptoms the next day after second dose; very sick; slight fever; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events experienced flu like symptoms the next day after second dose, very sick, slight fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events, experienced flu like symptoms the next day after second dose, very sick, slight fever.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced flu like symptoms the next day after second dose, very sick, slight fever was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient reported little rash, soreness on the right arm and back of arm and actual back on same; Patient reported little rash, soreness on the right arm and back of arm and actual back on same; 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  little rash, soreness on the right arm and back of arm and actual back on same, feeling week and fatigue in the evening after receiving 2nd dose, patient started headache and severe joint pain(hips and back) ,patient got charlie horse on left calf, patient feels discomfort more on lower extremities as of now.  The patient's medical history was not provided. Concomitant medications reported were Metoprolol , Vitamin D, Vitamin B for drug use for unknown indication.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A)  in the left arm for prophylaxis of COVID-19 infection. On 1 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013A21A)  in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the event,patient reported little rash, soreness on the right arm and back of arm and actual back on same. On 1 Mar 2021, the patient experienced the event, patient started feeling week and fatigue in the evening after receiving 2nd dose. On 2 Mar 2021, the patient experienced the event,patient started headache and severe joint pain(hips and back) next day after receiving 2nd dose. On 4 Mar 2021, the patient experienced the event,patient got charlie horse on left calf. On 5 Mar 1903, the patient experienced the event,patient feels discomfort more on lower extremities as of now.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, patient reported little rash, soreness on the right arm and back of arm and actual back on same, patient started feeling week and fatigue in the evening after receiving 2nd dose, patient started headache and severe joint pain(hips and back) next day after receiving 2nd dose, patient got charlie horse on left calf, patient feels discomfort more on lower extremities as of now was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Severe allergy; 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 ALLERGY TO VACCINE (Severe allergy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severe allergy). At the time of the report, ALLERGY TO VACCINE (Severe allergy) 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Body aches; left arm pain at the site of the injection; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm pain at the site of the injection, body aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) left arm pain at the site of the injection, body aches.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), left arm pain at the site of the injection, body aches was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Very bad fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very bad fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Very bad fatigue). At the time of the report, FATIGUE (Very bad fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-036812, MOD-2021-036813, MOD-2021-036814 (E2B Linked Report).; Sender's Comments:  MOD-2021-036813:MOD21-046450:Same reporter,  Reporter's husband MOD-2021-036814:MOD21-046583:Same reporter, diferent patients MOD-2021-036812:MOD21-046584:Same reporter, invalid case
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; Muscle aches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-013926 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters in patient's hand and toes; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters in patient's hand and toes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included MS in 1991 and Autoimmune disorder. Concomitant products included AMLODIPINE for Hypertension, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 15-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced BLISTER (Blisters in patient's hand and toes). The patient was treated with CLOBETASOL PROPIONATE ongoing from 03-Mar-2021 for Adverse event, at a dose of dosage form. At the time of the report, BLISTER (Blisters in patient's hand and toes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient treatment data was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU appended, Medical information, patient details, concomitant medication and treatment medication were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Feeling abnormal, Hypersomnia
Clinical narrative: chest pain/chest was hurting like she was having hear attack; Hard to Breathe; Not able to stay awake; feeling terrible and crappy; Arm Hurting; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain/chest was hurting like she was having heart attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy) and VACCINATION SITE PAIN (Arm Hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHEST PAIN (chest pain/chest was hurting like she was having heart attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy), VACCINATION SITE PAIN (Arm Hurting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, CHEST PAIN (chest pain/chest was hurting like she was having hear attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy), VACCINATION SITE PAIN (Arm Hurting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            The patient reported that exactly 7days after the second dose it was like something hard had hit her, she went to the ER and they could not find anything specifically that is wrong with her but she said her chest was hurting like she was having heart attack, severe chest pain, very hard too breathe, her was arm hurting, chills, fever, not able to stay awake, sand he is feeling terrible and crappy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: chest pain/chest was hurting like she was having hear attack; Hard to Breathe; Not able to stay awake; feeling terrible and crappy; Arm Hurting; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain/chest was hurting like she was having heart attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy) and VACCINATION SITE PAIN (Arm Hurting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHEST PAIN (chest pain/chest was hurting like she was having heart attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy), VACCINATION SITE PAIN (Arm Hurting), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, CHEST PAIN (chest pain/chest was hurting like she was having hear attack), DYSPNOEA (Hard to Breathe), HYPERSOMNIA (Not able to stay awake), FEELING ABNORMAL (feeling terrible and crappy), VACCINATION SITE PAIN (Arm Hurting), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            The patient reported that exactly 7days after the second dose it was like something hard had hit her, she went to the ER and they could not find anything specifically that is wrong with her but she said her chest was hurting like she was having heart attack, severe chest pain, very hard too breathe, her was arm hurting, chills, fever, not able to stay awake, sand he is feeling terrible and crappy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary gland mucocoele
Clinical narrative: Mucosal cyst-inner lip; This spontaneous case was reported by a pharmacist and describes the occurrence of SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and 01Sm20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Feb-2021, the patient experienced SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip). At the time of the report, SALIVARY GLAND MUCOCOELE (Mucosal cyst-inner lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No lab data was provided. Treatment information was reported as the patient consulted HCP consulted via telemedicine and doctor prescribed Rx Keflex antibiotics.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: All Side effects listed in the package insert; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (All Side effects listed in the package insert) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION COMPLICATION (All Side effects listed in the package insert). At the time of the report, VACCINATION COMPLICATION (All Side effects listed in the package insert) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided  This case involves 5 unidentified patients.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient gender , initials, physical address, email updated
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchy rash on his right arm; red rash on his right arm; swelling on his right arm; red rash on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red rash on his right arm), VACCINATION SITE SWELLING (swelling on his right arm), VACCINATION SITE PRURITUS (itchy rash on his right arm) and VACCINATION SITE ERYTHEMA (red rash on his right arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (red rash on his right arm), VACCINATION SITE SWELLING (swelling on his right arm), VACCINATION SITE PRURITUS (itchy rash on his right arm) and VACCINATION SITE ERYTHEMA (red rash on his right arm). At the time of the report, VACCINATION SITE RASH (red rash on his right arm), VACCINATION SITE SWELLING (swelling on his right arm), VACCINATION SITE PRURITUS (itchy rash on his right arm) and VACCINATION SITE ERYTHEMA (red rash on his right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash around shot area; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around shot area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002A21A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient experienced the event(s) rash around shot area.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash around shot area was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is swollen bad, super swollen; Really red huge whelps about 3-4 inches; Itchy; Really bad headache; Body ache; Chills; Fever; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches), PRURITUS (Itchy) and HEADACHE (Really bad headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, DICLOFENAC and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 06-Mar-2021, the patient experienced HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Motrin, Anacin, Ice pack.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria papular
Clinical narrative: Arm is swollen bad, super swollen; Really red huge whelps about 3-4 inches; Itchy; Really bad headache; Body ache; Chills; Fever; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches), PRURITUS (Itchy) and HEADACHE (Really bad headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, DICLOFENAC and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 06-Mar-2021, the patient experienced HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Motrin, Anacin, Ice pack.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache pain left side of her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache pain left side of her head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0101421A) 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 07-Mar-2021, the patient experienced HEADACHE (Headache pain left side of her head). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache pain left side of her head) had not resolved.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-036855 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sneezing
Clinical narrative: Sneezing a lot; Woke up tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing a lot) and FATIGUE (Woke up tired) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Down's syndrome.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced SNEEZING (Sneezing a lot) and FATIGUE (Woke up tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SNEEZING (Sneezing a lot) and FATIGUE (Woke up tired) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: having some effects like nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (having some effects like nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcer.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced NAUSEA (having some effects like nausea). At the time of the report, NAUSEA (having some effects like nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of gout (flare-up of gout) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced gout (flare-up of gout). At the time of the report, gout (flare-up of gout) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: It itches; Some red; Arm swelled up in that area (injection site); Heat in it; A big knot in there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat in it), VACCINATION SITE MASS (A big knot in there), VACCINATION SITE PRURITUS (It itches), VACCINATION SITE SWELLING (Arm swelled up in that area (injection site)) and VACCINATION SITE ERYTHEMA (Some red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Heat in it), VACCINATION SITE MASS (A big knot in there) and VACCINATION SITE SWELLING (Arm swelled up in that area (injection site)). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (It itches) and VACCINATION SITE ERYTHEMA (Some red). At the time of the report, VACCINATION SITE WARMTH (Heat in it), VACCINATION SITE MASS (A big knot in there), VACCINATION SITE PRURITUS (It itches), VACCINATION SITE SWELLING (Arm swelled up in that area (injection site)) and VACCINATION SITE ERYTHEMA (Some red) had not resolved.            Concomitant medications included high blood pressure medication. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; A spontaneous report was received from a pharmacist concerning a 92-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after the first dose of vaccination some point the patient experienced shingles  No treatment details provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event shingles was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Nausea, Oropharyngeal pain
Clinical narrative: diarrhea; sore throat; felt weak; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro, sulfa drugs.). Concomitant products included LISINOPRIL, CARVEDILOL, PRAVASTATIN, LEVOTHYROXINE, AMLODIPINE and TELMISARTAN for an unknown indication.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas). At the time of the report, DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), ASTHENIA (felt weak) and NAUSEA (nauseas) outcome was unknown.            Treatment was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Tooth infection
Clinical narrative: Severe tooth infection; Sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Severe tooth infection), ILLNESS (Sick) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (Severe tooth infection), ILLNESS (Sick) and PYREXIA (Fever). At the time of the report, TOOTH INFECTION (Severe tooth infection), ILLNESS (Sick) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Antibiotics.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain
Clinical narrative: Body aches; Diarrhea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, WARFARIN, EZETIMIBE and WARFARIN SODIUM (JANTOVEN) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), DIARRHOEA (Diarrhea), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mass, Myalgia, Nonspecific reaction, Peripheral swelling
Clinical narrative: odd reaction; hives in her upper body; hives in her back; hives in her neck; body aches; feeling kind headache; upper left arm started swollen; lump; very itching; all body itching; chest rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (chest rash). On 20-Feb-2021, the patient experienced PRURITUS (all body itching). On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching). On 26-Feb-2021, the patient experienced URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), MYALGIA (body aches) and HEADACHE (feeling kind headache). On an unknown date, the patient experienced NONSPECIFIC REACTION (odd reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump), PRURITUS (very itching), URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), RASH (chest rash), MYALGIA (body aches) and HEADACHE (feeling kind headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were supplements, blood pressure medications: Hydrochlorothiazide 25 mg and diuretic for blood pressure.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: odd reaction; hives in her upper body; hives in her back; hives in her neck; body aches; feeling kind headache; upper left arm started swollen; lump; very itching; all body itching; chest rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced RASH (chest rash). On 20-Feb-2021, the patient experienced PRURITUS (all body itching). On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump) and PRURITUS (very itching). On 26-Feb-2021, the patient experienced URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), MYALGIA (body aches) and HEADACHE (feeling kind headache). On an unknown date, the patient experienced NONSPECIFIC REACTION (odd reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (all body itching), NONSPECIFIC REACTION (odd reaction), PERIPHERAL SWELLING (upper left arm started swollen), MASS (lump), PRURITUS (very itching), URTICARIA (hives in her upper body), URTICARIA (hives in her back), URTICARIA (hives in her neck), RASH (chest rash), MYALGIA (body aches) and HEADACHE (feeling kind headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were supplements, blood pressure medications: Hydrochlorothiazide 25 mg and diuretic for blood pressure.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (diagnosed with shingles) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and ACICLOVIR (ZOVIRAX [ACICLOVIR]) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (diagnosed with shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included pain medicine.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Trouble in her ear; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Trouble in her ear) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Trouble in her ear). The patient was treated with AMOXICILLIN for Ear injury, at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (Trouble in her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tenderness, Toothache
Clinical narrative: Tooth pain gone; soreness; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), TENDERNESS (tenderness) and TOOTHACHE (Tooth pain gone) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Dental treatment NOS.    On 27-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 PAIN (soreness) and TENDERNESS (tenderness). On an unknown date, the patient experienced TOOTHACHE (Tooth pain gone). The patient was treated with CLINDAMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 28-Feb-2021, PAIN (soreness) and TENDERNESS (tenderness) had resolved. At the time of the report, TOOTHACHE (Tooth pain gone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. Other treatment details include Topical Creams.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red). At the time of the report, vaccination site induration (hard on left arm) and vaccination site erythema (wells that are red) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported.