chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Swelling is there / a hard lump about the size of golf ball appeared under armpit; Itchy rash at injection site; Gland under arm is sore; headache; fatigue; Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit; had a faint  itchy rash at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache) and FATIGUE (fatigue) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bee sting (Hives and illness.), Hives and Illness (due to bee sting). Concurrent medical conditions included Asthma and Hay fever. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) from June 2020 to an unknown date for Birth control, ESCITALOPRAM from April 2012 to an unknown date for Depression and Anxiety.    On 19-Mar-2021, 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 20-Mar-2021, the patient experienced SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache), FATIGUE (fatigue), LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) and VACCINATION SITE RASH (had a faint  itchy rash at injection site). On 21-Mar-2021, VACCINATION SITE PRURITUS (Itchy rash at injection site) and VACCINATION SITE RASH (had a faint  itchy rash at injection site) had resolved. On 02-Apr-2021, SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), HEADACHE (headache), FATIGUE (fatigue) and LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) had resolved. At the time of the report, LYMPH NODE PAIN (Gland under arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-237386 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated Patient details, medical history, updated Rechallenge fields,concomitant medication, outcome event from Unknown to Recovered, added new events Vaccination site rash, Vaccination site pruritus
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Swelling is there / a hard lump about the size of golf ball appeared under armpit; Itchy rash at injection site; Gland under arm is sore; headache; fatigue; Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit; had a faint  itchy rash at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache) and FATIGUE (fatigue) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bee sting (Hives and illness.), Hives and Illness (due to bee sting). Concurrent medical conditions included Asthma and Hay fever. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI-SPRINTEC) from June 2020 to an unknown date for Birth control, ESCITALOPRAM from April 2012 to an unknown date for Depression and Anxiety.    On 19-Mar-2021, 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 20-Mar-2021, the patient experienced SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), VACCINATION SITE PRURITUS (Itchy rash at injection site), LYMPH NODE PAIN (Gland under arm is sore), HEADACHE (headache), FATIGUE (fatigue), LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) and VACCINATION SITE RASH (had a faint  itchy rash at injection site). On 21-Mar-2021, VACCINATION SITE PRURITUS (Itchy rash at injection site) and VACCINATION SITE RASH (had a faint  itchy rash at injection site) had resolved. On 02-Apr-2021, SWELLING (Swelling is there / a hard lump about the size of golf ball appeared under armpit), HEADACHE (headache), FATIGUE (fatigue) and LYMPHADENOPATHY (Swollen gland under her arm since she got the shot / the size of a golf ball appeared under my armpit) had resolved. At the time of the report, LYMPH NODE PAIN (Gland under arm is sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.   This case was linked to MOD-2021-237386 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Updated Patient details, medical history, updated Rechallenge fields,concomitant medication, outcome event from Unknown to Recovered, added new events Vaccination site rash, Vaccination site pruritus
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site rash
Clinical narrative: rash, half an inch in diameter, at the injection site; pain at the injection site; pink mark" at the injection site; This case was received via an unknown source no reference has been entered for a health authority on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION, VACCINATION SITE RASH, and VACCINATION SITE PAIN in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 23-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION and VACCINATION SITE PAIN. On 30-Mar-2021, the patient experienced VACCINATION SITE RASH. On 28-Mar-2021, VACCINATION SITE DISCOLOURATION and VACCINATION SITE PAIN had resolved. At the time of the report, VACCINATION SITE RASH had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Device malfunction, Incorrect dose administered
Clinical narrative: Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of; Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 30-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of). At the time of the report, INCORRECT DOSE ADMINISTERED (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) and DEVICE MALFUNCTION (Due to mal-function of syringe, the dose didn't get in patient's arm instead it went into eyes of) had resolved. 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This report refers to a case of incorrect dose administered, device malfunction for mRNA-1273, lot # 018B21A with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache
Clinical narrative: Dizziness; weakness; Chills; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM, MIRTAZAPINE, FAMOTIDINE and PANTOPRAZOLE for an unknown indication.   On 29-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 29-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (weakness), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 which contains no new information, the reporter hung up phone after reason for call was explained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: site of injection is hard; site of injection is itchy; site of injection is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red). On 30-Mar-2021, VACCINATION SITE INDURATION (site of injection is hard), VACCINATION SITE PRURITUS (site of injection is itchy) and VACCINATION SITE ERYTHEMA (site of injection is red) outcome was unknown.        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: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Recurring hives breakout all over body; Itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Recurring hives breakout all over body) and PRURITUS (Itching) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (Recurring hives breakout all over body) and PRURITUS (Itching). At the time of the report, URTICARIA (Recurring hives breakout all over body) and PRURITUS (Itching) outcome was unknown.            Treatment Benadryll, zyrtec, atarax, and doctor recently changed zyrtec to Claritin.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: 2nd shot warm arm; 2nd shot sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm). At the time of the report, VACCINATION SITE WARMTH (2nd shot warm arm) and VACCINATION SITE PAIN (2nd shot sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: body achy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PAIN (body achy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     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 PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (body achy). At the time of the report, PAIN IN EXTREMITY (sore arm) and PAIN (body achy) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Sore throat; Runny nose; Congestion; Chills; Fatigue; Felt very depleted; Headache; Muscle aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Rhinorrhoea, Vomiting
Clinical narrative: Sore throat; Runny nose; Congestion; Chills; Fatigue; Felt very depleted; Headache; Muscle aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congestion), CHILLS (Chills), FATIGUE (Fatigue), FATIGUE (Felt very depleted), HEADACHE (Headache), MYALGIA (Muscle aches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle ache; Joint ache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache). On 25-Mar-2021, MYALGIA (Muscle ache) and ARTHRALGIA (Joint ache) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information included, ibuprofen and paracetamol was provided.   This case was linked to MOD-2021-030252 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030252:Same patient, 2nd shot
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pyrexia, Rash
Clinical narrative: felt like a truck hit her; chills; temperature of 101; rash on arms, hands, and tops of knees; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like a truck hit her), RASH (rash on arms, hands, and tops of knees), CHILLS (chills) and PYREXIA (temperature of 101) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on arms, hands, and tops of knees). On an unknown date, the patient experienced FEELING ABNORMAL (felt like a truck hit her), CHILLS (chills) and PYREXIA (temperature of 101). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt like a truck hit her), RASH (rash on arms, hands, and tops of knees), CHILLS (chills) and PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein amniotic fluid, Amniocentesis, Exposure during pregnancy, Pregnancy test, Prenatal screening test
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Moderate use). Family history included Birt-Hogg-Dube syndrome (Family genetic disease: maternal side, including mother, grandmother), Breast cancer (From maternal side), Colon cancer (From maternal side), Leukemia (From maternal side) and Heart disease, unspecified (On paternal side). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Dec-2020 and the estimated date of delivery was 13-Sep-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Pregnancy test: positive (Positive) Positive. On 25-Feb-2021, Prenatal screening test: normal (normal) Normal. On 08-Apr-2021, Alpha 1 foetoprotein amniotic fluid: normal (normal) Normal. On 28-Apr-2021, Amniocentesis: normal (normal) Normal, 20 week US.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event (Exposure during pregnancy) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information received on 10-May-2021, patients date of birth, gestation period (22 weeks), relevant medical history [Family genetic disease: Birt-Hogge Dube, cancers (breast, colon, leukemia), heart disease],  date of positive pregnancy test, diagnostic findings (Cell Free DNA, AFP, 20 week US), Alcohol use (moderate use).
Sex: M
Vaccine: COVID19
Symptoms: Cough, Eye movement disorder, Migraine, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat; Cough; Fever; Nausea; Migraine headache; Can't turn eyes left or right; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough) and PYREXIA (Fever) in a 21-year-old male 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, MIGRAINE (Migraine headache) and EYE MOVEMENT DISORDER (Can't turn eyes left or right) had not resolved and OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore throat; Cough; Fever; Nausea; Migraine headache; Can't turn eyes left or right; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough) and PYREXIA (Fever) in a 21-year-old male 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MIGRAINE (Migraine headache), EYE MOVEMENT DISORDER (Can't turn eyes left or right), PYREXIA (Fever) and NAUSEA (Nausea). On 30-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, MIGRAINE (Migraine headache) and EYE MOVEMENT DISORDER (Can't turn eyes left or right) had not resolved and OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Developmental delay since 31-May-1978.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021 at 2:54 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together). On 22-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received the 1st dose on 21Feb2021 and the 2nd dose on 22Feb2021 at different facilities and provided 2 different cards/Doses given too close together) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Third dose of vaccination was not given to the patient.   This case was linked to MOD21-065252 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up document was received. Patient's race, ethnicity, relevant medical history, vaccine route of administration, anatomical location, event start and stop date were added. It contains significant information. On 02-Jul-2021: Follow-up document was received. Vaccine route of administration and anatomical location were updated. No severe reaction was reported to either dose of the vaccine. It contains significant information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza
Clinical narrative: she felt like she was getting the flu; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (she felt like she was getting the flu), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (she felt like she was getting the flu), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 05-Mar-2021, INFLUENZA (she felt like she was getting the flu) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic, Epistaxis, Pain in extremity, Vaccination site mass
Clinical narrative: Pain in arm; lump size more than 50c coin in injection site; lump on injection site; nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), EPISTAXIS (nose bleeding), VACCINATION SITE MASS (lump size more than 50c coin in injection site) and VACCINATION SITE SWELLING (lump on injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (nose bleeding). On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (lump on injection site). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency and CLONIDINE for Adverse event, at a dose of 1 UNK. On 19-Mar-2021, PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site) had resolved. At the time of the report, EPISTAXIS (nose bleeding) outcome was unknown and VACCINATION SITE SWELLING (lump on injection site) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated. On 10-Mar-2021, Blood pressure systolic: 208 (High) increased.         patient lab data contain diastolic blood pressure done on 10 Mar 2021. Patient visited emergency room with elevated blood pressure and was treated by Norvasc and hydralazine. Patient had previously High blood pressure and treated it by metoprolol and lisinopril but never had so unexpected elevations. Occasionally Patient had experienced nose bleeding after vaccination and Physician added clonidine to patient's daily medication to treat the symptoms.   Crosslinked with case MOD21-065683 Caller was returning call from safety, contact information was provided.  The caller does not have a computer, and has no way to receive e-mail.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: initial addition information received on 14 May 2021 reporter information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Pain in arm; lump size more than 50c coin in injection site; lump on injection site; nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), EPISTAXIS (nose bleeding), VACCINATION SITE MASS (lump size more than 50c coin in injection site) and VACCINATION SITE SWELLING (lump on injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced EPISTAXIS (nose bleeding). On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (lump on injection site). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site). The patient was treated with AMLODIPINE BESILATE (NORVASC) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency and CLONIDINE for Adverse event, at a dose of 1 UNK. On 19-Mar-2021, PAIN IN EXTREMITY (Pain in arm) and VACCINATION SITE MASS (lump size more than 50c coin in injection site) had resolved. At the time of the report, EPISTAXIS (nose bleeding) outcome was unknown and VACCINATION SITE SWELLING (lump on injection site) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated. On 10-Mar-2021, Blood pressure systolic: 208 (High) increased.         patient lab data contain diastolic blood pressure done on 10 Mar 2021. Patient visited emergency room with elevated blood pressure and was treated by Norvasc and hydralazine. Patient had previously High blood pressure and treated it by metoprolol and lisinopril but never had so unexpected elevations. Occasionally Patient had experienced nose bleeding after vaccination and Physician added clonidine to patient's daily medication to treat the symptoms.   Crosslinked with case MOD21-065683 Caller was returning call from safety, contact information was provided.  The caller does not have a computer, and has no way to receive e-mail.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: initial addition information received on 14 May 2021 reporter information updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries) and dizziness (weird/dazed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040A21A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 30, 2021, patient experienced asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries), dizziness (weird/dazed) and headache. The patient was treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), dizziness (weird/dazed) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries) and dizziness (weird/dazed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040A21A) for COVID-19 vaccination. The occurrence of additional events detailed below. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 30, 2021, patient experienced asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), peripheral swelling (fingers & tiptoes looked like cherries), dizziness (weird/dazed) and headache. The patient was treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, asthenia (felt like passed out), pain (felt all the body like punctured by needles), pain in extremity (sore arm), dizziness (weird/dazed) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy exposure; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, 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 04-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 02-Oct-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 02-Oct-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy exposure) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue) in a 55-year-old female patient 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 29-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Received less than half the dose; Needle Leaked; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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 30-Mar-2021, the patient experienced UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked). On 30-Mar-2021, UNDERDOSE (Received less than half the dose) and DEVICE CONNECTION ISSUE (Needle Leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea; Vaccination is a little bit itchy; Vaccination is a little bit red; Arm pit has lymph nodes; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red), LYMPHADENOPATHY (Arm pit has lymph nodes) and LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red) and LYMPHADENOPATHY (Arm pit has lymph nodes). On 22-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red) and LYMPHADENOPATHY (Arm pit has lymph nodes) had resolved and LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other relevant concomitant medication were reported. No treatment medication were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain on her feet; pain mostly on her knee; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her feet) and ARTHRALGIA (pain mostly on her knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 immunisation.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Aspirin Allergy).   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on her feet). 28-Mar-2021, the patient experienced ARTHRALGIA (pain mostly on her knee). In May 2021, PAIN IN EXTREMITY (pain on her feet) and ARTHRALGIA (pain mostly on her knee) had resolved with sequelae.            Concomitant medications were not provided Treatment information was not provided. Patient Reported that she was Recovered with residual effects (Knee Pain). Patient had experienced similar event in the past (Light knee pain) but it was not that painful. Her knees hurt when she walked.   This case was linked to US-MODERNATX, INC.-MOD-2021-035726 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received: Added Patient Demographics, Medical History, Vaccine Information (site), Event outcome (Recovered/Resolved with Sequelae).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035726: 2nd dose.