chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: pain in his Right; hardness at the injection site; i had fever; i felt like something was moving in my back; feel a bit of hot; cold; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (pain in his Right) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot) and NASOPHARYNGITIS (cold). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, PYREXIA (i had fever), MOVEMENT DISORDER (i felt like something was moving in my back), FEELING HOT (feel a bit of hot), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (pain in his Right) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided Treatment for the events were not provided
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN and METOPROLOL for Diabetes.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Treatment information is not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Left arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Adverse event.    No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm was sore). At the time of the report, PAIN IN EXTREMITY (Left arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-029836 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient received the two doses of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergic rhinitis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 03-Feb-2021 to an unknown date for Allergic rhinitis, ACETYLSALICYLIC ACID (ASPIRIN 81) from 03-Feb-2021 to an unknown date for Hypertension, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 24-Dec-2020 to an unknown date for Pregnancy.   On 27-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Dec-2020 and the estimated date of delivery was 07-Sep-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 24-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the two doses of the Moderna vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, Pregnancy test: positive (Positive) Positive. On 13-Apr-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data include Glucose tolerance on 01JUN2021 not yet completed .  The patient did not have any complications or acute illnesses during this pregnancy till date.  Treatment for the event was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Pyrexia, Swelling
Clinical narrative: weakness; diarrhea; swelling; chills; high fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills) and PYREXIA (high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting) 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.   Concomitant drug included Blood pressure medication. Patient reported that she began to feel better on 24-Mar-2021.  Treatment medication was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: weakness; diarrhea; swelling; chills; high fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills) and PYREXIA (high fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting). At the time of the report, ASTHENIA (weakness), DIARRHOEA (diarrhea), SWELLING (swelling), CHILLS (chills), PYREXIA (high fever) and VOMITING (vomiting) 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.   Concomitant drug included Blood pressure medication. Patient reported that she began to feel better on 24-Mar-2021.  Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeling drunk
Clinical narrative: woozy", lightheaded, and felt fatigue; "as if when you feel drunk."; just wanted to put her head down.; woozy", lightheaded, and felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozy", lightheaded, and felt fatigue), FATIGUE (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE (woozy", lightheaded, and felt fatigue). On 24-Mar-2021, the patient experienced DIZZINESS (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.). At the time of the report, DIZZINESS (woozy", lightheaded, and felt fatigue), FATIGUE (woozy", lightheaded, and felt fatigue), FEELING DRUNK ("as if when you feel drunk.") and ASTHENIA (just wanted to put her head down.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were not provided. No treatment medication information were not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Upper-airway cough syndrome
Clinical narrative: Post Nasal Dripping; Exposed to COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus) and UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus). On 24-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus) and UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administered to patient of inappropriate age
Clinical narrative: Administration of an invalid dose (storage and use on pediatrics); Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administration of an invalid dose (storage and use on pediatrics)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M21A) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administration of an invalid dose (storage and use on pediatrics)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 22-Mar-2021, POOR QUALITY PRODUCT ADMINISTERED (Administration of an invalid dose (storage and use on pediatrics)) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-056335 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caught Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (Caught Covid). At the time of the report, COVID-19 (Caught Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: unknown (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were given by the reporter. No treatment information were provided by the reporter. Patient stated that she has finished her quarantine on 23-Mar-2021
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine inadvertantly administered to patient less than 18 yrs of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine inadvertantly administered to patient less than 18 yrs of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: ADR form was received and the following information was updated: Reporter information, patient Dose one lot number and vaccine date.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (15 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid + between doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid + between doses) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid + between doses). At the time of the report, COVID-19 (Covid + between doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Fatigue, Feeling cold, Headache
Clinical narrative: whole body Extremely Cold; chills; 101 F. fever; body aches; tired; extreme headache (migraine?); nauseous; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat) outcome was unknown.            This case was linked to MOD21-061522 (E2B Linked Report).; Sender's Comments:  MOD21-061522:MOD-2021-056430 Cross-Linked with patient case
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: whole body Extremely Cold; chills; 101 F. fever; body aches; tired; extreme headache (migraine?); nauseous; can't eat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (whole body Extremely Cold), CHILLS (chills), PYREXIA (101 F. fever), PAIN (body aches), FATIGUE (tired), HEADACHE (extreme headache (migraine?)), NAUSEA (nauseous) and EATING DISORDER (can't eat) outcome was unknown.            This case was linked to MOD21-061522 (E2B Linked Report).; Sender's Comments:  MOD21-061522:MOD-2021-056430 Cross-Linked with patient case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bone pain, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Swelling and pain in armpit; Swelling and pain on collarbone; Swelling in armpit and on collarbone; Soreness; Tiredness; Stiffness in right arm; injection site swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness) and AXILLARY PAIN (Swelling and pain in armpit) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling) and MUSCULOSKELETAL STIFFNESS (Stiffness in right arm). On 08-Feb-2021, the patient experienced FATIGUE (Tiredness) and PAIN (Soreness). On 09-Feb-2021, the patient experienced AXILLARY PAIN (Swelling and pain in armpit) and BONE PAIN (Swelling and pain on collarbone). 09-Feb-2021, the patient experienced SWELLING (Swelling in armpit and on collarbone). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness), AXILLARY PAIN (Swelling and pain in armpit), BONE PAIN (Swelling and pain on collarbone) and SWELLING (Swelling in armpit and on collarbone) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that 6 hours after vaccination, the patient had injection site swelling and stiffness in right arm.   This case was linked to MOD-2021-031080 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Swelling and pain in armpit; Swelling and pain on collarbone; Swelling in armpit and on collarbone; Soreness; Tiredness; Stiffness in right arm; injection site swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness) and AXILLARY PAIN (Swelling and pain in armpit) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling) and MUSCULOSKELETAL STIFFNESS (Stiffness in right arm). On 08-Feb-2021, the patient experienced FATIGUE (Tiredness) and PAIN (Soreness). On 09-Feb-2021, the patient experienced AXILLARY PAIN (Swelling and pain in armpit) and BONE PAIN (Swelling and pain on collarbone). 09-Feb-2021, the patient experienced SWELLING (Swelling in armpit and on collarbone). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) in February 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE SWELLING (injection site swelling), MUSCULOSKELETAL STIFFNESS (Stiffness in right arm), FATIGUE (Tiredness), PAIN (Soreness), AXILLARY PAIN (Swelling and pain in armpit), BONE PAIN (Swelling and pain on collarbone) and SWELLING (Swelling in armpit and on collarbone) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that 6 hours after vaccination, the patient had injection site swelling and stiffness in right arm.   This case was linked to MOD-2021-031080 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered dose to 17 years old 2 male patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 17 years old 2 male patients) 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.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (two 17 year old males) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Localized rash on arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Localized rash on arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Localized rash on arm at the injection site). At the time of the report, VACCINATION SITE RASH (Localized rash on arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Stool analysis
Clinical narrative: Dehydration; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydration) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Glaucoma since an unknown date. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN and METOPROLOL for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced DEHYDRATION (Dehydration). At the time of the report, DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydration) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Stool analysis: no blood in stools (Inconclusive) No blood in stools.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Follow up received on 06-apr-2021 and does not contain any new information On 06-Apr-2021: TCR received on 06-Apr-2021 and does not contain any new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (patient took Alcohol from 2010 to 01-JAN-2021, 3 to 5 beers a week.) from 2010 to 01-Jan-2021. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 24-Mar-2021 at 11:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Nov-2020 and the estimated date of delivery was 17-Sep-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Pregnancy test: positive (Positive) positive. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The estimated date of conception was 17-Dec-2020. Genetic testing and Ultrasounds were Normal on an unknown date. Previous pregnancy reported on 09-May-2020 without any complications.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient wants to sleep all the time after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient wants to sleep all the time after the second dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SOMNOLENCE (Patient wants to sleep all the time after the second dose). At the time of the report, SOMNOLENCE (Patient wants to sleep all the time after the second dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia
Clinical narrative: a fever of 103; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (a fever of 103), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache; Fever of 98.9-99.9; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 98.9-99.9) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 98.9-99.9) and CHILLS (Chills). The patient was treated with IBUPROFEN from 23-Mar-2021 to 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 98.9-99.9) and CHILLS (Chills) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient reported taking ibuprofen on 23-Mar-2021, another dose morning on 24-Mar-2021 at 9:30, and another dose afternoon on 24-Mar-2021 at 4.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 virus) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus). At the time of the report, COVID-19 (Tested positive for COVID-19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19 virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dehydration, Fatigue, Vomiting
Clinical narrative: He was dehydrated; He experienced upset stomach; He experienced fatigue; He vomited; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (He was dehydrated), ABDOMINAL DISCOMFORT (He experienced upset stomach), FATIGUE (He experienced fatigue) and VOMITING (He vomited) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (He experienced fatigue) and VOMITING (He vomited). On an unknown date, the patient experienced DEHYDRATION (He was dehydrated) and ABDOMINAL DISCOMFORT (He experienced upset stomach). At the time of the report, DEHYDRATION (He was dehydrated), ABDOMINAL DISCOMFORT (He experienced upset stomach), FATIGUE (He experienced fatigue) and VOMITING (He vomited) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Memory impairment, Migraine
Clinical narrative: Migraine; Lethargy; Fuzzy memory; Fever at the injection site; Swelling at the injection site/swollen to softball size; Gets up and lays back down; Headache/head exploding at top; Bodyache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), LETHARGY (Lethargy), MEMORY IMPAIRMENT (Fuzzy memory), VACCINATION SITE WARMTH (Fever at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Cholesterol and Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure abnormal, EZETIMIBE for Cholesterol, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MIGRAINE (Migraine), LETHARGY (Lethargy), VACCINATION SITE WARMTH (Fever at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size), FATIGUE (Gets up and lays back down), HEADACHE (Headache/head exploding at top) and MYALGIA (Bodyache). 13-Mar-2021, the patient experienced MEMORY IMPAIRMENT (Fuzzy memory). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine), LETHARGY (Lethargy), MEMORY IMPAIRMENT (Fuzzy memory), VACCINATION SITE WARMTH (Fever at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size), FATIGUE (Gets up and lays back down), HEADACHE (Headache/head exploding at top) and MYALGIA (Bodyache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included usage of steroid cream and ice.  It was reported that Patient had no improvements with symptoms despite treatments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Migraine; Lethargy; Fuzzy memory; Fever at the injection site; Swelling at the injection site/swollen to softball size; Gets up and lays back down; Headache/head exploding at top; Bodyache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), LETHARGY (Lethargy), MEMORY IMPAIRMENT (Fuzzy memory), VACCINATION SITE WARMTH (Fever at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Cholesterol and Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure abnormal, EZETIMIBE for Cholesterol, METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MIGRAINE (Migraine), LETHARGY (Lethargy), VACCINATION SITE WARMTH (Fever at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size), FATIGUE (Gets up and lays back down), HEADACHE (Headache/head exploding at top) and MYALGIA (Bodyache). 13-Mar-2021, the patient experienced MEMORY IMPAIRMENT (Fuzzy memory). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine), LETHARGY (Lethargy), MEMORY IMPAIRMENT (Fuzzy memory), VACCINATION SITE WARMTH (Fever at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site/swollen to softball size), FATIGUE (Gets up and lays back down), HEADACHE (Headache/head exploding at top) and MYALGIA (Bodyache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included usage of steroid cream and ice.  It was reported that Patient had no improvements with symptoms despite treatments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site mass, Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: her arm was very very red to the elbow; itchy; warm; swollen; a hard lump at the injection site that lasted for 2 weeks; her skin started to peel; Her arm is a little bit discolored; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen) and INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, LISINOPRIL, METOPROLOL, FOLIC ACID, LEVOTHYROXINE, SIMVASTATIN and FUROSEMIDE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen), INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks), SKIN EXFOLIATION (her skin started to peel) and SKIN DISCOLOURATION (Her arm is a little bit discolored). At the time of the report, ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen), INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks), SKIN EXFOLIATION (her skin started to peel) and SKIN DISCOLOURATION (Her arm is a little bit discolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment includes Benadryl roll-on anti-itch
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Skin warm
Clinical narrative: her arm was very very red to the elbow; itchy; warm; swollen; a hard lump at the injection site that lasted for 2 weeks; her skin started to peel; Her arm is a little bit discolored; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen) and INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, LISINOPRIL, METOPROLOL, FOLIC ACID, LEVOTHYROXINE, SIMVASTATIN and FUROSEMIDE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen), INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks), SKIN EXFOLIATION (her skin started to peel) and SKIN DISCOLOURATION (Her arm is a little bit discolored). At the time of the report, ERYTHEMA (her arm was very very red to the elbow), PRURITUS (itchy), SKIN WARM (warm), PERIPHERAL SWELLING (swollen), INJECTION SITE MASS (a hard lump at the injection site that lasted for 2 weeks), SKIN EXFOLIATION (her skin started to peel) and SKIN DISCOLOURATION (Her arm is a little bit discolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment includes Benadryl roll-on anti-itch
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchy skin; Pinkish skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin) 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 PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin). At the time of the report, PRURITUS (Itchy skin) and ERYTHEMA (Pinkish skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in an elderly female patient (gravida 1) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.