chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypertension, Pruritus, Rash
Clinical narrative: Hypertension; itchy; redness; hot; rash that travelled down her arm to elbow and under hand; Vaccination site swelling; Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy) and ERYTHEMA (redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy), ERYTHEMA (redness), FEELING HOT (hot) and RASH (rash that travelled down her arm to elbow and under hand). At the time of the report, HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy), ERYTHEMA (redness), FEELING HOT (hot) and RASH (rash that travelled down her arm to elbow and under hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Hypertension; itchy; redness; hot; rash that travelled down her arm to elbow and under hand; Vaccination site swelling; Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy) and ERYTHEMA (redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy), ERYTHEMA (redness), FEELING HOT (hot) and RASH (rash that travelled down her arm to elbow and under hand). At the time of the report, HYPERTENSION (Hypertension), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash), PRURITUS (itchy), ERYTHEMA (redness), FEELING HOT (hot) and RASH (rash that travelled down her arm to elbow and under hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar high; A spontaneous report was received from consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood sugar high.  The patient's current conditions include type 2 diabetes mellitus and blood pressure abnormal. Concomitant medications reported were insulin for blood sugar, pills for blood sugar and blood pressure pills.  On 01 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Feb 2021, one day after receiving the vaccine, the patient's blood sugar was high. The patient stated that she was a diabetic type-2 patient and she took her pills and insulin for blood sugar, but still with high sugar.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, blood sugar high was considered as not resolved.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of diabetes confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Just a little soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little soreness on the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis (in remission) since 15-Sep-2018. Concomitant products included BUDESONIDE from 01-Oct-2018 to an unknown date for Diarrhea.    On 27-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Just a little soreness on the injection site). At the time of the report, VACCINATION SITE PAIN (Just a little soreness on the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Reporter Information updated, Patient Medical History and Concomitant Medications added,
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: WOKE UP WITH A TREMENDOUS HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021 at 10:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE). At the time of the report, HEADACHE (WOKE UP WITH A TREMENDOUS HEADACHE) had not resolved.            No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles in her scalp; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles in her scalp) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   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 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles in her scalp). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (shingles in her scalp) outcome was unknown.            No concomitant medication were provided    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow received on 29-APR-2021 : Consumer declined Consent.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided and concomitant drugs are provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 04-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-102237 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Dizziness, Headache
Clinical narrative: Exacerbate his symptoms from his back surgery; Back pain; Leg Spasms; Increased back spasms; Achiness; Dizziness; Chills; Nausea; Headache; Fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms) and PAIN (Achiness) in a 65-year-old male 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.     The patient's past medical history included COVID-19 in November 2020 and Spinal stenosis (Multiple surgeries conducted NOS). Concomitant products included GABAPENTIN and MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F). At the time of the report, VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 99.2 (Inconclusive) 99.2. In November 2020, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Exacerbate his symptoms from his back surgery; Back pain; Leg Spasms; Increased back spasms; Achiness; Dizziness; Chills; Nausea; Headache; Fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms) and PAIN (Achiness) in a 65-year-old male 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.     The patient's past medical history included COVID-19 in November 2020 and Spinal stenosis (Multiple surgeries conducted NOS). Concomitant products included GABAPENTIN and MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F). At the time of the report, VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 99.2 (Inconclusive) 99.2. In November 2020, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Exacerbate his symptoms from his back surgery; Back pain; Leg Spasms; Increased back spasms; Achiness; Dizziness; Chills; Nausea; Headache; Fever of 99.2 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms) and PAIN (Achiness) in a 65-year-old male 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.     The patient's past medical history included COVID-19 in November 2020 and Spinal stenosis (Multiple surgeries conducted NOS). Concomitant products included GABAPENTIN and MELOXICAM for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F). At the time of the report, VACCINATION COMPLICATION (Exacerbate his symptoms from his back surgery), BACK PAIN (Back pain), MUSCLE SPASMS (Leg Spasms), MUSCLE SPASMS (Increased back spasms), PAIN (Achiness), DIZZINESS (Dizziness), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99.2 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Body temperature: 99.2 (Inconclusive) 99.2. In November 2020, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Pruritus, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: itch a lot; rash on right arm, and a little bit on left one as well, and mainly on back; swelling of the injection site; red circle around the area the size of a baseball; lump/knot in the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE MASS (lump/knot in the injection site), VACCINATION SITE SWELLING (swelling of the injection site) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball). On 02-Mar-2021, the patient experienced PRURITUS (itch a lot) and RASH (rash on right arm, and a little bit on left one as well, and mainly on back). On 02-Mar-2021, VACCINATION SITE SWELLING (swelling of the injection site) had resolved. At the time of the report, INJECTION SITE MASS (lump/knot in the injection site), PRURITUS (itch a lot), RASH (rash on right arm, and a little bit on left one as well, and mainly on back) and VACCINATION SITE ERYTHEMA (red circle around the area the size of a baseball) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain
Clinical narrative: Sore Armpit (Injected Arm); Sore breast on movement; Sore Shoulder (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)). At the time of the report, AXILLARY PAIN (Sore Armpit (Injected Arm)), BREAST PAIN (Sore breast on movement) and ARTHRALGIA (Sore Shoulder (Injected Arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were given No treatment information was provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: rm was just a little red below the injection site after first dose; rm was just a little red below the injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose). At the time of the report, VACCINATION SITE ERYTHEMA (rm was just a little red below the injection site after first dose) and VACCINATION SITE BRUISING (rm was just a little red below the injection site after first dose) outcome was unknown. Not Provided          No treatment information was provided.    This case was linked to MOD-2021-028240 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Have a fatty tumor and think that they shot it in there instead of in muscle; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of events, the patient's received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of Covid-19 infection.  On 26 Feb 2021, after she received the vaccine, the patient reported instead of putting the shot into the muscle, the patient had a fatty tumor and think that they shot it in there. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, instead of putting the shot into their muscle, they have a fatty tumor and think they shot it in there was considered as resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: little tender to touch; a red rash at the injection site; felt warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm). At the time of the report, VACCINATION SITE PAIN (little tender to touch), VACCINATION SITE RASH (a red rash at the injection site) and VACCINATION SITE WARMTH (felt warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Emergency care, Pruritus, Urticaria
Clinical narrative: was taken to ER and given some treatment; Itchy; Hives, ended up spread in many parts of her body,; This spontaneous case was reported by a consumer and describes the occurrence of EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Thyroid disorder NOS and Thrombocythemia.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK and PREDNISONE at an unspecified dose and frequency. At the time of the report, EMERGENCY CARE (was taken to ER and given some treatment), PRURITUS (Itchy) and URTICARIA (Hives, ended up spread in many parts of her body,) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was given steroid injection,Benadryl injection and prednisone pills as a treatment medication. Concomitant Medication included unspecified cholesterol medication , thyroid medication, quimo drug pill for type.  It was reported that that the patient had many problems after she had the shot and it was unknown if it was related to the shot.  Her problems lasted for 3 months.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: F/U received on 21-JUN-2021,Clinical course information and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Didn't sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep all night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INSOMNIA (Didn't sleep all night). At the time of the report, INSOMNIA (Didn't sleep all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: headache; 99.8°F low grade fever; Pain at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills). At the time of the report, HEADACHE (headache), PYREXIA (99.8°F low grade fever), VACCINATION SITE PAIN (Pain at injection site) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: (Low) Low grade fever 99.8 F.         This case was linked to MOD-2021-046584 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Bump/ball the size of a quarter size not raised; Itchy; Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE PAIN (Slight soreness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     no medical history is provided and concomitant drugs are provided.  Concomitant products included IRON and PANTOPRAZOLE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness). On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised) and VACCINATION SITE PRURITUS (Itchy). On 02-Feb-2021, VACCINATION SITE MASS (Bump/ball the size of a quarter size not raised) outcome was unknown, VACCINATION SITE PAIN (Slight soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment provided was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu like symptoms; nausea; chills; body aches; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever) in a 65-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.     Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication, ESTRADIOL (ESTRADOT).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (flu like symptoms) 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.   Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; nausea; chills; body aches; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever) in a 65-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.     Concomitant products included LEVOTHYROXINE and PROGESTERONE for an unknown indication, ESTRADIOL (ESTRADOT).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, NAUSEA (nausea), CHILLS (chills), MYALGIA (body aches), FATIGUE (fatigue), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (flu like symptoms) 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.   Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: couldn't get the second dose; A spontaneous report  was received from a HCP concerning about a 41 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of missed the second dose.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) via intramuscular in left arm for prophylaxis of COVID-19 infection.  On an unknown date in the month of Feb 2021, the patient realized that she missed her second dose of vaccination as she had to leave the country.  Laboratory tests was not reported.  Treatment information was not provided.  All the events occurred after first dose of vaccination.  Action taken with mRNA-1273 in response to the events are unknown.  The outcome of event not applicable; Reporter's Comments: This report refers to a case of missed second dose of mRNA-1273 unintentionally, with no associated AEs.  Causality for the medication error is not applicable.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Erythema, Fatigue, Feeling hot, Peripheral swelling
Clinical narrative: arm was red; arm was hot; arm was swollen; there was a rash on their neck in the side where they got the vaccine with redness on it; itching a lot on their back and ear and the palm of their hand; very very tired, terribly fatigued; it was like a hive on their upper lip; ears started itching; threw up some liquid that night; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and PERIPHERAL SWELLING (arm was swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seafood allergy (shellfish), Seasonal allergy (Seasonal) and Allergy to plants (Christmas trees). Concomitant products included LISINOPRIL, FAMOTIDINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTICS NOS for an unknown indication.    On 10-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 URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching) and VOMITING (threw up some liquid that night). On 22-Feb-2021, the patient experienced ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued). The patient was treated with SERTRALINE HYDROCHLORIDE ongoing since an unknown date at an unspecified dose and frequency. On 10-Feb-2021, VOMITING (threw up some liquid that night) had resolved. At the time of the report, URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 10-Feb-2021, the patient took (Sertaline) 30 minutes before getting the vaccine.  Her doctor wanted her to have the Moderna vaccine since it was the least allergic one.  No other treatment was reported.   This case was linked to MOD-2021-028289 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria, Vomiting
Clinical narrative: arm was red; arm was hot; arm was swollen; there was a rash on their neck in the side where they got the vaccine with redness on it; itching a lot on their back and ear and the palm of their hand; very very tired, terribly fatigued; it was like a hive on their upper lip; ears started itching; threw up some liquid that night; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and PERIPHERAL SWELLING (arm was swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seafood allergy (shellfish), Seasonal allergy (Seasonal) and Allergy to plants (Christmas trees). Concomitant products included LISINOPRIL, FAMOTIDINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTICS NOS for an unknown indication.    On 10-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 URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching) and VOMITING (threw up some liquid that night). On 22-Feb-2021, the patient experienced ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued). The patient was treated with SERTRALINE HYDROCHLORIDE ongoing since an unknown date at an unspecified dose and frequency. On 10-Feb-2021, VOMITING (threw up some liquid that night) had resolved. At the time of the report, URTICARIA (it was like a hive on their upper lip), EAR PRURITUS (ears started itching), ERYTHEMA (arm was red), FEELING HOT (arm was hot), PERIPHERAL SWELLING (arm was swollen), RASH ERYTHEMATOUS (there was a rash on their neck in the side where they got the vaccine with redness on it), PRURITUS (itching a lot on their back and ear and the palm of their hand) and FATIGUE (very very tired, terribly fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 10-Feb-2021, the patient took (Sertaline) 30 minutes before getting the vaccine.  Her doctor wanted her to have the Moderna vaccine since it was the least allergic one.  No other treatment was reported.   This case was linked to MOD-2021-028289 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: headache; muscle pain; joint pain; chills; nausea; fever(100.8); headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the second episode of HEADACHE (headache). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Adverse event, at a dose of UNK dosage form. On 20-Feb-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the last episode of HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; muscle pain; joint pain; chills; nausea; fever(100.8); headache; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced the first episode of HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the second episode of HEADACHE (headache). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (MOTRIN COLD & FLU) for Adverse event, at a dose of UNK dosage form. On 20-Feb-2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever(100.8)) and the last episode of HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bone pain, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Bone pain; Tremors; difficulty breathing since her nose and throat seem stuffy; No appetite; no taste; Upper arm pain; nose and throat seem stuffy; fever; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite) and AGEUSIA (no taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Lactose) and Colon cancer.   On 20-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), PAIN IN EXTREMITY (Upper arm pain), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (Upper arm pain) had not resolved.            The patient did not take any concomitant medications. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter address, patient demographics, medical history, first dose date and lot number, additional event, medically confim.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Bone pain; Tremors; difficulty breathing since her nose and throat seem stuffy; No appetite; no taste; Upper arm pain; nose and throat seem stuffy; fever; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite) and AGEUSIA (no taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Lactose) and Colon cancer.   On 20-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), PAIN IN EXTREMITY (Upper arm pain), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (Upper arm pain) had not resolved.            The patient did not take any concomitant medications. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter address, patient demographics, medical history, first dose date and lot number, additional event, medically confim.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Bone pain; Tremors; difficulty breathing since her nose and throat seem stuffy; No appetite; no taste; Upper arm pain; nose and throat seem stuffy; fever; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite) and AGEUSIA (no taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011m20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Lactose) and Colon cancer.   On 20-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), PAIN IN EXTREMITY (Upper arm pain), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain), TREMOR (Tremors), DYSPNOEA (difficulty breathing since her nose and throat seem stuffy), DECREASED APPETITE (No appetite), AGEUSIA (no taste), NASAL CONGESTION (nose and throat seem stuffy), PYREXIA (fever), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (Upper arm pain) had not resolved.            The patient did not take any concomitant medications. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Reporter address, patient demographics, medical history, first dose date and lot number, additional event, medically confim.