chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Extreme muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Extreme muscle soreness) 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 MYALGIA (Extreme muscle soreness). At the time of the report, MYALGIA (Extreme muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment medication reported Upon in internal review on 24 May 2021, the age was corrected to unknown age
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Lymphadenopathy
Clinical narrative: muscle pain; joint pain; headache; dizziness; lymph node swelling under both arms; extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness) and LYMPHADENOPATHY (lymph node swelling under both arms) in a 68-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. No concomitant medication reported.    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 MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness), LYMPHADENOPATHY (lymph node swelling under both arms) and FATIGUE (extreme fatigue). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness), LYMPHADENOPATHY (lymph node swelling under both arms) and FATIGUE (extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; joint pain; headache; dizziness; lymph node swelling under both arms; extreme fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness) and LYMPHADENOPATHY (lymph node swelling under both arms) in a 68-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. No concomitant medication reported.    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 MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness), LYMPHADENOPATHY (lymph node swelling under both arms) and FATIGUE (extreme fatigue). At the time of the report, MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache), DIZZINESS (dizziness), LYMPHADENOPATHY (lymph node swelling under both arms) and FATIGUE (extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema
Clinical narrative: Warm to touch; Red area at site of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING HOT (Warm to touch) and VACCINATION SITE ERYTHEMA (Red area at site of injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M20A) for COVID-19 vaccination.     No medical history report provided by the reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Warm to touch) and VACCINATION SITE ERYTHEMA (Red area at site of injection). At the time of the report, FEELING HOT (Warm to touch) and VACCINATION SITE ERYTHEMA (Red area at site of injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was given Advil on 17 Mar 2021 to treat AE.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 july 2021 and it contains no new information.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VOMITING (vomiting). At the time of the report, VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No  treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: patient may have been administered a 1 ml dose; patient may have been administered a 1 ml dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient may have been administered a 1 ml dose/incorrect dose administered and overdose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via intramuscular route at unknown location for prophylaxis of COVID-19 infection.  On unknown date patient may have been administered more than the recommended 0.5 ml dose of the vaccine. The patient may have been administered a 1 ml dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided  The outcome for the events incorrect dose administered and overdose was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and overdose for mRNA-1273 with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; Only sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A, 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE PAIN (Only sore to touch) outcome was unknown.            No Concomitant Medication was provided.  No treatment  was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Feeling hot, Limb discomfort, Musculoskeletal stiffness
Clinical narrative: Musculoskeletal stiffness; Skin warm; Rash; Chills; Feeling hot; Disorientation; Limb discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) and SKIN WARM (Skin warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-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 12-Mar-2021, the patient experienced LIMB DISCOMFORT (Limb discomfort). On 13-Mar-2021, the patient experienced FEELING HOT (Feeling hot), DISORIENTATION (Disorientation) and CHILLS (Chills). On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm) and RASH (Rash). At the time of the report, FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm), RASH (Rash) and CHILLS (Chills) outcome was unknown.            Treatment of the events included Benadryl total of 4 tablets and Claritin - 1 pill
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: Musculoskeletal stiffness; Skin warm; Rash; Chills; Feeling hot; Disorientation; Limb discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) and SKIN WARM (Skin warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-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 12-Mar-2021, the patient experienced LIMB DISCOMFORT (Limb discomfort). On 13-Mar-2021, the patient experienced FEELING HOT (Feeling hot), DISORIENTATION (Disorientation) and CHILLS (Chills). On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm) and RASH (Rash). At the time of the report, FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm), RASH (Rash) and CHILLS (Chills) outcome was unknown.            Treatment of the events included Benadryl total of 4 tablets and Claritin - 1 pill
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Illness, SARS-CoV-2 antibody test positive
Clinical narrative: felt very sick; tested positive for Covid-19 after 1st vaccination; cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (felt very sick), COVID-19 (tested positive for Covid-19 after 1st vaccination) and COUGH (cough) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (felt very sick), COVID-19 (tested positive for Covid-19 after 1st vaccination) and COUGH (cough). At the time of the report, ILLNESS (felt very sick) and COVID-19 (tested positive for Covid-19 after 1st vaccination) had not resolved and COUGH (cough) outcome was unknown. Not Provided   Treatment: cough syrup   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 antibody test positive:positive patient was tested for Covid-19 and  result were positive..     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.   This case was linked to MOD21-056970 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-056970:Crosslinked Patient with Husband case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown. Not Provided          No Concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was Not applicable.   This case was linked to MOD21-057158 (E2B Linked Report).; Sender's Comments:  MOD21-057158:Cosslinked wife case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Feeling abnormal, Headache, Lymphadenopathy, Nasopharyngitis
Clinical narrative: Serious sore throat; Achiness; Runny nose; Felt horrible; Splitting headache; Throbbing neck glands on both sides; Swollen neck glands on both sides; Voice sounding like she has a cold; Unevaluable reaction; Left eye throbbing; A spontaneous report  was received from consumer, concerning herself, a 55-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unevaluable reaction, felt horrible, splitting headache, serious sore throat, left eye throbbing, runny nose, swollen neck glands on both sides, throbbing neck glands on both sides, voice sounding like she has a cold, and achiness.   The patient has a prior history of penicillin allergy.  On 16 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: F038A21A) via unknown route on left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, after receiving the vaccine, the patient felt like she stroke like symptoms such as swollen left side of the face, puffy left side of the face, drooling, could barely move and felt horrible and abnormal. She also had headache, throat pain, left eye pain, runny nose, swollen and painful neck gland.  She rested staying on bed having water and food. The patient returned to work on 18 Mar 2021.   The patient is nervous to take the second dose of vaccine and commented that she will probably not take the second dose in the future.   Action taken with mRNA-1273 in response to events was not provided.  Th events felt horrible, throbbing neck glands on both sides, runny nose, unevaluable reaction, serious sore throat and achiness were considered resolved. The events, splitting headache, swollen neck glands on both sides, voice sounding like she has a cold  and left eye throbbing were considered resolving.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Rhinorrhoea, Unevaluable event
Clinical narrative: Serious sore throat; Achiness; Runny nose; Felt horrible; Splitting headache; Throbbing neck glands on both sides; Swollen neck glands on both sides; Voice sounding like she has a cold; Unevaluable reaction; Left eye throbbing; A spontaneous report  was received from consumer, concerning herself, a 55-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced unevaluable reaction, felt horrible, splitting headache, serious sore throat, left eye throbbing, runny nose, swollen neck glands on both sides, throbbing neck glands on both sides, voice sounding like she has a cold, and achiness.   The patient has a prior history of penicillin allergy.  On 16 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: F038A21A) via unknown route on left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, after receiving the vaccine, the patient felt like she stroke like symptoms such as swollen left side of the face, puffy left side of the face, drooling, could barely move and felt horrible and abnormal. She also had headache, throat pain, left eye pain, runny nose, swollen and painful neck gland.  She rested staying on bed having water and food. The patient returned to work on 18 Mar 2021.   The patient is nervous to take the second dose of vaccine and commented that she will probably not take the second dose in the future.   Action taken with mRNA-1273 in response to events was not provided.  Th events felt horrible, throbbing neck glands on both sides, runny nose, unevaluable reaction, serious sore throat and achiness were considered resolved. The events, splitting headache, swollen neck glands on both sides, voice sounding like she has a cold  and left eye throbbing were considered resolving.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Confusional state, Fatigue, Headache, Myalgia
Clinical narrative: chest pain; swollen; He is not working due to pain; throat scrapes; confusion; body ache; headache; fatigue; temperature; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes) and CONFUSIONAL STATE (confusion) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 015M20A) 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 11-Feb-2021, 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 15-Mar-2021, the patient experienced CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature). At the time of the report, CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator No treatment medications provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-023421.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023421:1st dose
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain, Pyrexia, Swelling
Clinical narrative: chest pain; swollen; He is not working due to pain; throat scrapes; confusion; body ache; headache; fatigue; temperature; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes) and CONFUSIONAL STATE (confusion) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 015M20A) 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 11-Feb-2021, 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 15-Mar-2021, the patient experienced CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature). At the time of the report, CHEST PAIN (chest pain), SWELLING (swollen), PAIN (He is not working due to pain), OROPHARYNGEAL DISCOMFORT (throat scrapes), CONFUSIONAL STATE (confusion), MYALGIA (body ache), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (temperature) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator No treatment medications provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2021-023421.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023421:1st dose
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: sore arm; This spontaneous case was reported by a physical therapist and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Allergy nos). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MONASCUS PURPUREUS (RED YEAST RICE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). On 05-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) result came back positive on (18Mar2021).     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information were not provided. Patient experienced nasal congestion as symptoms of COVID-19.   This case was linked to US-MODERNATX, INC.-MOD-2021-049944 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Non-Significant follow up received. Added symptoms of COVID-19 in narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049944:crosslink, seperate case for 2 nd dose of vaccine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Sore arm; Not felt normal for a week; Fatigue; Strong head ache in first few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days) in a 39-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Feb-2021, the adult was diagnosed with PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The adult was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Not felt normal for a week), FATIGUE (Fatigue) and HEADACHE (Strong head ache in first few days) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-049952, MOD-2021-050069, MOD-2021-050206, MOD-2021-049952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non-significant follow-up, contact information added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Headache, Heart rate increased, Hot flush
Clinical narrative: congestion; Hot flashes; Dizziness; Tingling in nose and throat; Trouble breathing because of rapid heart beat; Blood pressure was elevated; felt lethargic and weak; nauseated; Soreness in muscle; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Soreness in muscle), NASAL CONGESTION (congestion), NAUSEA (nauseated) and HOT FLUSH (Hot flashes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Soreness in muscle). On 16-Mar-2021, the patient experienced NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak). The patient was treated with CETIRIZINE HYDROCHLORIDE (oral) on 16-Mar-2021 at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (Headache) and MYALGIA (Soreness in muscle) had resolved. On 16-Mar-2021, NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nasal congestion, Nausea, Paraesthesia
Clinical narrative: congestion; Hot flashes; Dizziness; Tingling in nose and throat; Trouble breathing because of rapid heart beat; Blood pressure was elevated; felt lethargic and weak; nauseated; Soreness in muscle; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Soreness in muscle), NASAL CONGESTION (congestion), NAUSEA (nauseated) and HOT FLUSH (Hot flashes) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Soreness in muscle). On 16-Mar-2021, the patient experienced NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak). The patient was treated with CETIRIZINE HYDROCHLORIDE (oral) on 16-Mar-2021 at an unspecified dose and frequency. On 11-Mar-2021, HEADACHE (Headache) and MYALGIA (Soreness in muscle) had resolved. On 16-Mar-2021, NASAL CONGESTION (congestion), NAUSEA (nauseated), HOT FLUSH (Hot flashes), DIZZINESS (Dizziness), PARAESTHESIA (Tingling in nose and throat), HEART RATE INCREASED (Trouble breathing because of rapid heart beat), BLOOD PRESSURE MEASUREMENT (Blood pressure) and LETHARGY (felt lethargic and weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Headache, Laziness, Vaccination site pain
Clinical narrative: headaches; Severe lightheadedness/ dizzy; could not walk/ stagger with a couple steps/ could not walk without help; soreness in her arm; Vomited/ threw up liquid; Little Lazy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LAZINESS (Little Lazy), DIZZINESS (Severe lightheadedness/ dizzy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arteriovenous malformation (AVM (Arteriovenous malformation) near the thalamus).   On 11-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 14-Mar-2021, the patient experienced DIZZINESS (Severe lightheadedness/ dizzy). In March 2021, the patient experienced LAZINESS (Little Lazy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid). On an unknown date, the patient experienced HEADACHE (headaches). In March 2021, LAZINESS (Little Lazy) and DIZZINESS (Severe lightheadedness/ dizzy) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) had resolved and HEADACHE (headaches) outcome was unknown. Not Provided          Patient spent six hours in the Emergency room and had tests done to rule out heart failure and blood clots. All tests are normal and heart is fine.Patient had a CT scan.     Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021 and contact information was updated On 10-Aug-2021: Significant follow-up received on 10-AUG-2021 included medical history of arteriovenous malformation near the thalamus was updated. additional ne event of headache was added and event LLT pain in arm was changed to vaccination site pain.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headaches; Severe lightheadedness/ dizzy; could not walk/ stagger with a couple steps/ could not walk without help; soreness in her arm; Vomited/ threw up liquid; Little Lazy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LAZINESS (Little Lazy), DIZZINESS (Severe lightheadedness/ dizzy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arteriovenous malformation (AVM (Arteriovenous malformation) near the thalamus).   On 11-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 14-Mar-2021, the patient experienced DIZZINESS (Severe lightheadedness/ dizzy). In March 2021, the patient experienced LAZINESS (Little Lazy), GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid). On an unknown date, the patient experienced HEADACHE (headaches). In March 2021, LAZINESS (Little Lazy) and DIZZINESS (Severe lightheadedness/ dizzy) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk/stagger with a couple steps, could not walk without help), VACCINATION SITE PAIN (soreness in her arm) and VOMITING (Vomited/ threw up liquid) had resolved and HEADACHE (headaches) outcome was unknown. Not Provided          Patient spent six hours in the Emergency room and had tests done to rule out heart failure and blood clots. All tests are normal and heart is fine.Patient had a CT scan.     Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021 and contact information was updated On 10-Aug-2021: Significant follow-up received on 10-AUG-2021 included medical history of arteriovenous malformation near the thalamus was updated. additional ne event of headache was added and event LLT pain in arm was changed to vaccination site pain.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Swelling, Urticaria, Vaccination site pruritus
Clinical narrative: Injection site warmth to touch; arm where I recived the shot broke out with a rash; Injection site itch; hives; red swelling; red swelling; severe bout of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling), SWELLING (red swelling) and VACCINATION SITE WARMTH (Injection site warmth to touch) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Prone to having hives occasionally but haven't had them in recent years). Concurrent medical conditions included Cholesterol since 15-Dec-2019. Concomitant products included ATORVASTATIN from 15-Dec-2019 to an unknown date for Cholesterol.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (severe bout of diarrhea). On 12-Mar-2021, the patient experienced URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLALANINE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE;PHENYLALANINE]) for Itching, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling) had resolved and VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch) had not resolved.            The patient never been diagnosed with/ tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Followup information received on 09-May-2021 and contains following information: Patient Address, contact number, email address were added, vaccination information of  both doses of the vaccine were added, Patient demographics Age, height, weight, initials and race were added, concomitant medications and information about the events were updated.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Injection site warmth to touch; arm where I recived the shot broke out with a rash; Injection site itch; hives; red swelling; red swelling; severe bout of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling), SWELLING (red swelling) and VACCINATION SITE WARMTH (Injection site warmth to touch) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Prone to having hives occasionally but haven't had them in recent years). Concurrent medical conditions included Cholesterol since 15-Dec-2019. Concomitant products included ATORVASTATIN from 15-Dec-2019 to an unknown date for Cholesterol.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (severe bout of diarrhea). On 12-Mar-2021, the patient experienced URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLALANINE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE;PHENYLALANINE]) for Itching, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe bout of diarrhea), URTICARIA (hives), ERYTHEMA (red swelling) and SWELLING (red swelling) had resolved and VACCINATION SITE WARMTH (Injection site warmth to touch), VACCINATION SITE RASH (arm where I recived the shot broke out with a rash) and VACCINATION SITE PRURITUS (Injection site itch) had not resolved.            The patient never been diagnosed with/ tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Followup information received on 09-May-2021 and contains following information: Patient Address, contact number, email address were added, vaccination information of  both doses of the vaccine were added, Patient demographics Age, height, weight, initials and race were added, concomitant medications and information about the events were updated.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Memory impairment, Pain in extremity, Rash
Clinical narrative: Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per; A sore arm; A rash; Soreness at the site; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Malignant neoplasm of upper-outer quadrant of female breast. Concomitant products included TUCATINIB (TUKYSA) for Breast cancer female, TUCATINIB (TUKYSA) for Malignant neoplasm of upper-outer quadrant of female breast.    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 MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site). At the time of the report, MEMORY IMPAIRMENT (Missed a couple of doses due to forgetting/oes occasionally miss a dose - approximately 1 dose per), PAIN IN EXTREMITY (A sore arm), RASH (A rash) and INJECTION SITE PAIN (Soreness at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  Tukysa 50mg and 150mg is being discontinued due to no longer working.  Most recent follow up: Does occasionally miss a dose - approximately 1 dose per month   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Non-Significant Follow-up added On 05-Aug-2021: Significant follow-up was received on 05-AUG-2021 and added co suspect medication details.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pain of skin, Peripheral swelling, Rash
Clinical narrative: Rashes with stinging sensation, pain and swelling on palms; Rashes with stinging sensation, pain and swelling on palms; Rashes with stinging sensation, pain and swelling on palms; Rshes with stinging sensation, pain and swelling on palms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms). At the time of the report, RASH (Rashes with stinging sensation, pain and swelling on palms), PAIN OF SKIN (Rashes with stinging sensation, pain and swelling on palms), PAIN IN EXTREMITY (Rashes with stinging sensation, pain and swelling on palms) and PERIPHERAL SWELLING (Rshes with stinging sensation, pain and swelling on palms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter  Treatment information was not provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness; This spontaneous case was reported by a physician and describes the occurrence of   in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not reported). Concomitant products included WARFARIN SODIUM (COUMADIN), VITAMIN D NOS, EZETIMIBE (ZETIA) and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CODEINE at an unspecified dose and frequency and FENTANYL at an unspecified dose and frequency.        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 reported by investigator
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Slightly itchy; Rash on the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm). At the time of the report, RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: follow up received: second dose added