chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of inappropriate schedule of product administration (second dose after 8 weeks) and herpes zoster (had a bout of shingles) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013M20A) for COVID-19 vaccination. No medical history reported. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (second dose after 8 weeks) and herpes zoster (had a bout of shingles). At the time of the report, inappropriate schedule of product administration (second dose after 8 weeks) and herpes zoster (had a bout of shingles) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: severe pain in body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe pain in body) 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 (severe pain in body). At the time of the report, MYALGIA (severe pain in body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    This case was linked to MOD21-084369 (E2B Linked Report).; Sender's Comments:  MOD21-084369:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ( pain in her arm that comes and goes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN IN EXTREMITY ( pain in her arm that comes and goes). At the time of the report, PAIN IN EXTREMITY ( pain in her arm that comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported  Treatment medication information were not reported   This case was linked to MOD-2021-098370 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on right elbow; Rash on left elbow; Rash on right foot; Rash on left foot; Rash on palm of right hand; Rash on palm of left hand; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot) and RASH (Rash on palm of right hand) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot), RASH (Rash on palm of right hand) and RASH (Rash on palm of left hand). At the time of the report, RASH (Rash on right elbow), RASH (Rash on left elbow), RASH (Rash on right foot), RASH (Rash on left foot), RASH (Rash on palm of right hand) and RASH (Rash on palm of left hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient was prescribed steroid medication for the rashes.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: minor joint pain; minor muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included NADOLOL (CORGARD) and HYDROCHLOROTHIAZIDE for Blood pressure high, LOSARTAN for Blood pressure low, PAROXETINE HYDROCHLORIDE (PAXIL CR) for Depression and Anxiety, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for GERD, IBUPROFEN (ADVIL 12 HOUR) for Pain, POTASSIUM for Potassium low.    On 04-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 ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain). On 06-Mar-2021, ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain) outcome was unknown. Not Provided      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.   Patient was treated with Advil (Unknown strength and amount).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Rash macular, Skin burning sensation, Skin discolouration
Clinical narrative: It became raised and puffy with a red ring around the blotch; itchiness and pain is gone, the original blotch remains and is now a purplish color; Still itchy and a dull ache deep within my arm remained.; It was hot to the touch, itchy, burning; Itchy; Burning; I developed a red blotch about two inches below the injection site; Mild flu-like symptoms for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours). On 04-Apr-2021, the patient experienced RASH MACULAR (I developed a red blotch about two inches below the injection site). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning). On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.). On an unknown date, the patient experienced SWELLING (It became raised and puffy with a red ring around the blotch) and SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color). At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy), SKIN BURNING SENSATION (Burning), SWELLING (It became raised and puffy with a red ring around the blotch), SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color) and PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: It became raised and puffy with a red ring around the blotch; itchiness and pain is gone, the original blotch remains and is now a purplish color; Still itchy and a dull ache deep within my arm remained.; It was hot to the touch, itchy, burning; Itchy; Burning; I developed a red blotch about two inches below the injection site; Mild flu-like symptoms for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours). On 04-Apr-2021, the patient experienced RASH MACULAR (I developed a red blotch about two inches below the injection site). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy) and SKIN BURNING SENSATION (Burning). On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.). On an unknown date, the patient experienced SWELLING (It became raised and puffy with a red ring around the blotch) and SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color). At the time of the report, INFLUENZA LIKE ILLNESS (Mild flu-like symptoms for 24 hours), RASH MACULAR (I developed a red blotch about two inches below the injection site), VACCINATION SITE WARMTH (It was hot to the touch, itchy, burning), VACCINATION SITE PRURITUS (Itchy), SKIN BURNING SENSATION (Burning), SWELLING (It became raised and puffy with a red ring around the blotch), SKIN DISCOLOURATION (itchiness and pain is gone, the original blotch remains and is now a purplish color) and PAIN IN EXTREMITY (Still itchy and a dull ache deep within my arm remained.) outcome was unknown. Not Provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia
Clinical narrative: lost voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMPAGLIFLOZIN (JARDIANCE), METFORMIN, INSULIN GLARGINE (LANTUS), LIRAGLUTIDE (VICTOZA) and PIOGLITAZONE for an unknown indication.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced APHONIA (lost voice). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and GUAIFENESIN (ROBITUSSIN [GUAIFENESIN]) at an unspecified dose and frequency. At the time of the report, APHONIA (lost voice) had not resolved. Not Provided          Action taken with respect to mRNA-1273 was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Additional information provided that patient needed to took a deep breath for the voice to come out and states that the symptoms were ongoing. Patient denied experiencing sore throat or cough. No relief had received from the treatment    This case was linked to MOD-2021-098227 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: This morning my sugar was 550; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (This morning my sugar was 550) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.   On 28-Apr-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 29-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (This morning my sugar was 550). At the time of the report, BLOOD GLUCOSE INCREASED (This morning my sugar was 550) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Blood glucose: 550 (High) morning and 300 (High) after insulin.         Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28 JUNE 2021, updated the outcome of the event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Dry mouth, Fatigue, Lip disorder, Lip haemorrhage
Clinical narrative: Extreme thirst; Chapped lips; Bump on her bottom lip; Dry mouth; Lips started bleeding; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth) and LIP HAEMORRHAGE (Lips started bleeding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue). 24-Apr-2021, the patient experienced DRY MOUTH (Dry mouth). At the time of the report, THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medications were reported.  Patient used lip balm, but no additional treatment information for the events was reported. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Extreme thirst; Chapped lips; Bump on her bottom lip; Dry mouth; Lips started bleeding; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth) and LIP HAEMORRHAGE (Lips started bleeding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue). 24-Apr-2021, the patient experienced DRY MOUTH (Dry mouth). At the time of the report, THIRST (Extreme thirst), CHAPPED LIPS (Chapped lips), LIP DISORDER (Bump on her bottom lip), DRY MOUTH (Dry mouth), LIP HAEMORRHAGE (Lips started bleeding) and FATIGUE (Fatigue) outcome was unknown. Not Provided          No concomitant medications were reported.  Patient used lip balm, but no additional treatment information for the events was reported. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls; administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine) and PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) from 01-Jan-2010 to an unknown date for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (administered vaccine that was "not stored properly"/"room temperature since Monday"/incorrectly been given injections of an expired Moderna vaccine) and PRODUCT STORAGE ERROR (administered vaccine that was "not stored properly"/"room temperature since Monday"/syringes that were kept in non-sterile conditions without termperature or other controls) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included CELECOXIB (CELEBREX)  No treatment medication included.   This case was linked to MOD21-084222, MOD21-084255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Significant follow up received, patient demographics updated, out come of the event updated from unknown to recovered.; Sender's Comments:  MOD21-084222:cross linked id MOD21-084255:cross linked id
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-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 29-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medications were reported.   No corrective treatment was provided.  Action taken with respect to mRNA-1273 was not applicable.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Within a day or so (7April2021), the patient began to experience pretty severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Within a day or so (7April2021), the patient began to experience pretty severe headaches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Renal disease.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Within a day or so (7April2021), the patient began to experience pretty severe headaches). At the time of the report, HEADACHE (Within a day or so (7April2021), the patient began to experience pretty severe headaches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within a day or so (7April2021), the patient began to experience pretty severe headaches which lasted several days before going away completely. The patient took Tylenol as treatment.  No concomitant medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Has Fever of 99.5 degrees Fahrenheit; Nausea; Has Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Has Fever of 99.5 degrees Fahrenheit), NAUSEA (Nausea) and HEADACHE (Has Headaches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Has Fever of 99.5 degrees Fahrenheit), NAUSEA (Nausea) and HEADACHE (Has Headaches). At the time of the report, PYREXIA (Has Fever of 99.5 degrees Fahrenheit), NAUSEA (Nausea) and HEADACHE (Has Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99.5 (High) degrees Fahrenheit.         No concomitant medications were reported.  No corrective treatment was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080650 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information added on 29JUN2021 contains non significant follow up. Reporter stated in the email that she cannot fill out form as it is small and is a bad form. No new information added in case; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080650:Mother
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Initial insomnia, Limb discomfort, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: ¨the pain won´t let me sleep at night , the pain woke me up¨; ¨it seems to be a little Swollen¨; four hours after the injection, started having pain in the arm of the injection ( right arm); not able to move his right arm ; not able to lift the arm; the pain is constant; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨), LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant), VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)). On 29-Apr-2021, the patient experienced INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨) and VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INITIAL INSOMNIA (¨the pain won´t let me sleep at night , the pain woke me up¨), LIMB DISCOMFORT (not able to move his right arm ; not able to lift the arm), PAIN (the pain is constant), VACCINATION SITE SWELLING (¨it seems to be a little Swollen¨) and VACCINATION SITE PAIN (four hours after the injection, started having pain in the arm of the injection ( right arm)) outcome was unknown.        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.   No concomitant medications were provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-098298, US-MODERNATX, INC.-MOD-2021-098351 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098298: US-MODERNATX, INC.-MOD-2021-098351:Reporter case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia (high pain tolerance due to fibromyalgia) and High cholesterol. Concomitant products included DULOXETINE for Fibromyalgia, ROSUVASTATIN for High cholesterol, VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 800 mg. In March 2021, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to  (E2B Linked Report).; Sender's Comments:  :2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain above right breast when turning; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain above right breast when turning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, PARACETAMOL (TYLENOL) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced CHEST PAIN (Chest pain above right breast when turning). At the time of the report, CHEST PAIN (Chest pain above right breast when turning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      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.   Relevant concomitant medications were not reported.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-050270, US-MODERNATX, INC.-MOD-2021-050287, US-MODERNATX, INC.-MOD-2021-097800, US-MODERNATX, INC.-MOD-2021-098102 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-050270: US-MODERNATX, INC.-MOD-2021-050287: US-MODERNATX, INC.-MOD-2021-097800: US-MODERNATX, INC.-MOD-2021-098102:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Exposure to SARS-CoV-2, Myalgia, Nausea
Clinical narrative: FEVER; bad nausea; back pain for several days; bones were sore and painful; muscles were sore and painful; exposed to COVID after receiving her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful) and MYALGIA (muscles were sore and painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose). At the time of the report, PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient took Tylenol to treat symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; bad nausea; back pain for several days; bones were sore and painful; muscles were sore and painful; exposed to COVID after receiving her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful) and MYALGIA (muscles were sore and painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose). At the time of the report, PYREXIA (FEVER), NAUSEA (bad nausea), BACK PAIN (back pain for several days), BONE PAIN (bones were sore and painful), MYALGIA (muscles were sore and painful) and EXPOSURE TO SARS-COV-2 (exposed to COVID after receiving her 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient took Tylenol to treat symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fibromyalgia, Myalgia
Clinical narrative: fibromyalgia; severe joint pain; severe muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of FIBROMYALGIA (fibromyalgia), ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Depression, Anxiety, Potassium low and Blood pressure. Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE and NADOLOL (CORGARD) for Blood pressure, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression and Anxiety, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for GERD, POTASSIUM for Potassium low.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain). On an unknown date, the patient experienced FIBROMYALGIA (fibromyalgia). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (fibromyalgia), ARTHRALGIA (severe joint pain) and MYALGIA (severe muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-098269 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fibromyalgia, Headache, Pain in extremity, Paraesthesia
Clinical narrative: headache with pain in the eyebrow and temple area upper facial area; headache with pain in the eyebrow and temple area upper facial area; sore arm; pain in her hands to the point she could not hold a phone; pain in feet; tingling; fibromyalgia symptoms flared up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache with pain in the eyebrow and temple area upper facial area), FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone) and PAIN IN EXTREMITY (pain in feet) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027a21a and 002b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia. Concomitant products included DULOXETINE, ROSUVASTATIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (headache with pain in the eyebrow and temple area upper facial area) and FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area). In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone), PAIN IN EXTREMITY (pain in feet), PARAESTHESIA (tingling) and FIBROMYALGIA (fibromyalgia symptoms flared up). At the time of the report, HEADACHE (headache with pain in the eyebrow and temple area upper facial area), FACIAL PAIN (headache with pain in the eyebrow and temple area upper facial area), PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in her hands to the point she could not hold a phone), PAIN IN EXTREMITY (pain in feet), PARAESTHESIA (tingling) and FIBROMYALGIA (fibromyalgia symptoms flared up) outcome was unknown. Not Provided      Treatment information was provided i.e., acetaminophen, ibuprofen, vitamin C, butalbital/acetaminophen/caffeine  Action taken with mRNA-1273in response to the events was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098290:
Age: 56.0
Sex: M
Vaccine: COVID19
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 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045421A and 037A21B.) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included IBUPROFEN for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-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 (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown.            No treatment related information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-098384 (E2B Linked Report). This case was linked to MOD-2021-098353 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098384:Co-worker's case
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      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.   No concomitant medications reported. No treatment information provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), BENAZEPRIL, ATORVASTATIN CALCIUM (LIPITOR), MIRTAZAPINE (REMERON), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (Fatigue). On 01-Apr-2021, FATIGUE (Fatigue) had resolved. Not Provided          Patient has taken blood thinner, high blood pressure, cholesterol medicine as treatment.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red dots on her legs below her knee on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red dots on her legs below her knee on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included hypothyroidism.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red dots on her legs below her knee on her legs). The patient was treated with LEVOTHYROXINE ongoing since an unknown date at a dose of 50 mcg. At the time of the report, ERYTHEMA (red dots on her legs below her knee on her legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       50 mcg of levothyroxine is used as treatment medication.  No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098288 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098288:Reporter case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: He noticed rashes in both legs; itchy; headache; rash behind the right knee; at night, it starts to itch; pain in his head close to his eyes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee) and PRURITUS (at night, it starts to itch) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee), PRURITUS (at night, it starts to itch) and HEADACHE (pain in his head close to his eyes). At the time of the report, RASH (He noticed rashes in both legs), PRURITUS (itchy), HEADACHE (headache), RASH (rash behind the right knee), PRURITUS (at night, it starts to itch) and HEADACHE (pain in his head close to his eyes) outcome was unknown.            Treatment with Hydrocortisone 1%cream was provided for itchy events.   This case was linked to US-MODERNATX, INC.-MOD-2021-098384 (E2B Linked Report). This case was linked to MOD-2021-098321 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098384:Cross-linked
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Constipation, Nausea
Clinical narrative: Stomach didn't feel good; Stomach Cramps; Felt nauseas; Constipated very bad; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Heparin allergy), Drug allergy (NSAIDS allergy), Cholesterol on 18-May-1989, Myocardial infarction (MCI(mild)) since 18-May-1989 and Hypertension (High Blood Pressure) since 18-May-1989.   On 10-Mar-2021 at 1:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021 at 6:30 PM, the patient experienced CONSTIPATION (Constipated very bad). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas). The patient was treated with MACROGOL 3350 (MIRALAX) for Constipation, at a dose of 1 UNK and BISACODYL (LAXATIVE [BISACODYL]) for Constipation, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Constipated very bad), ABDOMINAL DISCOMFORT (Stomach didn't feel good), ABDOMINAL PAIN UPPER (Stomach Cramps) and NAUSEA (Felt nauseas) was resolving. Not Provided          No concomitant medications were reported.  Miralax is used as treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-100579 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up Information received on 18-MAR-2021 : updated product details, treatment medication details,updated outcome of events, added a new event. On 01-Jun-2021: Follow-up Information received on 01-JUN-2021: Facility Information Updated, Patient Demographic  details updated, Vaccination time updated, Concomitant Medications Updated,  Event information Updated On 07-Jun-2021: No new information received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100579:2nd dose case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red dots on her legs below her knee on her legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red dots on her legs below her knee on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 ERYTHEMA (red dots on her legs below her knee on her legs). At the time of the report, ERYTHEMA (red dots on her legs below her knee on her legs) outcome was unknown.            No treatment was taken.