chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen, Vaccination site pain
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink/day before pregnancy) in 2008 and Marijuana use. Concomitant products included PARACETAMOL (TYLENOL) for Pain management and Headache, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Oct-2020 to an unknown date and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 9:00 AM, 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 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred  on 08-May-2021, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. pre-eclampsia diagnosed on 07-May-2021, emergency C-section took place on 08-May-2021. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2020, Pregnancy test: positive (Positive) positive. On 15-Jan-2021, Ultrasound abdomen: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included unspecified antimalarial drugs.  Obstetric panel tests (first trimester maternal sequential screening panel) were conducted on 02-Nov-2020 which showed normal pregnancy-associated plasma protein A. On 11-Jan-2021, Maternal serum alpha fetoprotein screening test showed negative. Regular ultrasounds were normal.  The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during this pregnancy. Number of fetuses was reported as 1.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up received on 13 May 2021 added outcome of events, concomitant medications and laboratory details.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Feeling abnormal, Headache
Clinical narrative: Rapid heartbeat; Shaking all over; Eyes crossed; In general felt terrible; didn't get much sleep; Fever(102.4°F); Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible) and SLEEP DEFICIT (didn't get much sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with CLONIDINE for Blood pressure high, at an unspecified dose and frequency. On 31-Jan-2021, HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 200 mmHg (Inconclusive) 200 or something like that at 9pm. On 29-Jan-2021, Body temperature: 102.4 (High) at 9pm.         No concomitant medications were provided.    This case was linked to MOD21-16954 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Sleep deficit, Strabismus, Tremor
Clinical narrative: Rapid heartbeat; Shaking all over; Eyes crossed; In general felt terrible; didn't get much sleep; Fever(102.4°F); Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible) and SLEEP DEFICIT (didn't get much sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with CLONIDINE for Blood pressure high, at an unspecified dose and frequency. On 31-Jan-2021, HEART RATE INCREASED (Rapid heartbeat), TREMOR (Shaking all over), STRABISMUS (Eyes crossed), FEELING ABNORMAL (In general felt terrible), SLEEP DEFICIT (didn't get much sleep), PYREXIA (Fever(102.4°F)), CHILLS (Chills) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Blood pressure measurement: 200 mmHg (Inconclusive) 200 or something like that at 9pm. On 29-Jan-2021, Body temperature: 102.4 (High) at 9pm.         No concomitant medications were provided.    This case was linked to MOD21-16954 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Inappropriate scheduled of second dose (within 25 days); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) 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 (No medical history reported).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)). On 26-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of second dose (within 25 days)) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Relevant concomitant medications were not reported.  Treatment information was not provided.  This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown, with pain in extremity.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Pain in extremity
Clinical narrative: having headaches most everyday since the shot; Cough; COVID-19; Pain in legs; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included LISINOPRIL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). On 15-Jan-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced HEADACHE (having headaches most everyday since the shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form as required. On 13-Jan-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough) and HEADACHE (having headaches most everyday since the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up added- Patient reported new event and stated she did not fill the form as it is too big and detailed.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: having headaches most everyday since the shot; Cough; COVID-19; Pain in legs; Fatigue; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough), FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Osteoarthritis. Concomitant products included LISINOPRIL for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs). On 13-Jan-2021, the patient experienced COVID-19 (COVID-19). On 15-Jan-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced HEADACHE (having headaches most everyday since the shot). The patient was treated with IBUPROFEN at a dose of 1 dosage form as required. On 13-Jan-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), COVID-19 (COVID-19), COUGH (Cough) and HEADACHE (having headaches most everyday since the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up added- Patient reported new event and stated she did not fill the form as it is too big and detailed.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Headache, Hypokinesia
Clinical narrative: Can't raise that arm to use bands or wieghts; Losing function of that muscle; Left deltoid where she received both injections started hurting; Lower back ache; Couldn't sleep; Could hardly move; Felt Achy; Chills; Headache; Felt generally lousy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), INSOMNIA (Couldn't sleep), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and FEELING ABNORMAL (Felt generally lousy) in an 82-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.     Concurrent medical conditions included Thyroid disorder and Allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BACK PAIN (Lower back ache) and HYPOKINESIA (Could hardly move). On an unknown date, the patient experienced MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting). On 17-Feb-2021, FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 21-Feb-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting) had not resolved and HYPOKINESIA (Could hardly move) outcome was unknown.            Concomitant medications used by the patient included, thyroid and allergy medications.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events updated in follow up. On 04-Jun-2021: New events updated in follow up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mobility decreased, Muscle disorder, Myalgia, Vaccination site pain
Clinical narrative: Can't raise that arm to use bands or wieghts; Losing function of that muscle; Left deltoid where she received both injections started hurting; Lower back ache; Couldn't sleep; Could hardly move; Felt Achy; Chills; Headache; Felt generally lousy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), INSOMNIA (Couldn't sleep), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and FEELING ABNORMAL (Felt generally lousy) in an 82-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.     Concurrent medical conditions included Thyroid disorder and Allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache). On 20-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), BACK PAIN (Lower back ache) and HYPOKINESIA (Could hardly move). On an unknown date, the patient experienced MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting). On 17-Feb-2021, FEELING ABNORMAL (Felt generally lousy), MYALGIA (Felt Achy), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 21-Feb-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, MOBILITY DECREASED (Can't raise that arm to use bands or wieghts), MUSCLE DISORDER (Losing function of that muscle), BACK PAIN (Lower back ache) and VACCINATION SITE PAIN (Left deltoid where she received both injections started hurting) had not resolved and HYPOKINESIA (Could hardly move) outcome was unknown.            Concomitant medications used by the patient included, thyroid and allergy medications.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events updated in follow up. On 04-Jun-2021: New events updated in follow up.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: redness between the elbow and the shoulder; wheals between the elbow and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder). At the time of the report, ERYTHEMA (redness between the elbow and the shoulder) and URTICARIA (wheals between the elbow and shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment history was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Pain
Clinical narrative: weakness; pain over body; difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), PAIN (pain over body) and GAIT DISTURBANCE (difficulty walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood thinner.
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain, Sensory loss
Clinical narrative: I can't lift my left arm without excruciating pain from neck down to fingers; I can't lift my left arm without excruciating pain from neck down to fingers; could not feel left arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 25 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the vaccine on 25 Jan 2021, in left arm. Four hours after dose, she stated, I could not feel left arm all the way up to her neck'. It was twelve-thirty-one pm (post-meridiam) and patient stated, I can't lift my arm without excruciating pain from neck down to fingers'. No further information was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event could not feel left arm was unknown. The outcome of the event I can't lift my left arm without excruciating pain from neck down to fingers was not resolved.  The reporter did not provide an assessment for the events, could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Chills; Body aches; Sore throat; Hot at the injection site; Itchy circle at the injection site; vaccination site erythema; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and CHILLS (Chills) in a 24-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 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Body aches). On 25-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Chills; Body aches; Sore throat; Hot at the injection site; Itchy circle at the injection site; vaccination site erythema; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and CHILLS (Chills) in a 24-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 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Body aches). On 25-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE PRURITUS (Itchy circle at the injection site), VACCINATION SITE ERYTHEMA (vaccination site erythema), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site pain
Clinical narrative: nausea; injection site pain; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), NAUSEA (nausea) and VACCINATION SITE PAIN (injection site pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastroesophageal reflux disease. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (lightheadedness) and VACCINATION SITE PAIN (injection site pain). On 25-Jan-2021, the patient experienced NAUSEA (nausea). On 23-Jan-2021, DIZZINESS (lightheadedness) had resolved. On 24-Jan-2021, VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pallor, Vertigo
Clinical narrative: very pale; Vertigo; nauseated; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     The patient's past medical history included Pancreaticoduodenectomy (For pancreatitis). Concurrent medical conditions included Iodine contrast media allergy, Osteoporosis (worsening, now on Prolia (every 6 mos. injections).) since June 2014, Seasonal allergy, Acute pancreatitis (Recurrent) since May 2009, High cholesterol since December 2014, Carotid artery disease (Blocked carotid artery) since December 2014 and Asthma. Concomitant products included ATORVASTATIN for High cholesterol, DENOSUMAB (PROLIA) for Osteoporosis.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue). On 18-Feb-2021, PALLOR (very pale), VERTIGO (Vertigo), NAUSEA (nauseated) and FATIGUE (fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-271984 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added patient demographics, medical history and concomitant medications.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder, Vaccination site erythema
Clinical narrative: Lump on Tongue; Red mark on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, TONGUE DISORDER (Lump on Tongue) and VACCINATION SITE ERYTHEMA (Red mark on injection site) outcome was unknown.            The patient's concomitant medication was not reported.  It was reported that the patient was better now.  The action taken with mRNA with the events was considered as not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: The follow-up was received on 6-JULY-2021 and date of onset of event was updated.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Limb mass, Skin warm
Clinical narrative: Arm had redness; Arm warm to touch; Arm knot 4-5 inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches). On 21-Jan-2021, SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) had resolved. At the time of the report, ERYTHEMA (Arm had redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Bruises at the site with a size of a dime; It is warm to touch; Sore arm; Hardness on the site; Itchy at site; Red at site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site) and VACCINATION SITE PRURITUS (Itchy at site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site). At the time of the report, VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Bruises at the site with a size of a dime; It is warm to touch; Sore arm; Hardness on the site; Itchy at site; Red at site; Swelling on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site) and VACCINATION SITE PRURITUS (Itchy at site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site). At the time of the report, VACCINATION SITE BRUISING (Bruises at the site with a size of a dime), VACCINATION SITE WARMTH (It is warm to touch), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Hardness on the site), VACCINATION SITE PRURITUS (Itchy at site), VACCINATION SITE ERYTHEMA (Red at site) and VACCINATION SITE SWELLING (Swelling on the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for 24 hs; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick for 24 hs) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced ILLNESS (Sick for 24 hs). At the time of the report, ILLNESS (Sick for 24 hs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Upon in internal review on 21 May 2021, the age was corrected to unknown age. No relevant concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up was received on 06-JUL-2021: Contain No new information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Lip discolouration, Lip disorder, Lip swelling, Salivary hypersecretion, Swelling face
Clinical narrative: a swollen lower lip; White color; The swelling went down under the chin; bumpy; swollen flesh below the lower lip; spills some liquid on the side while she talks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy) and LIP SWELLING (swollen flesh below the lower lip) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included GLIPIZIDE, SITAGLIPTIN, HYDROCHLOROTHIAZIDE, VALSARTAN, PROBIOTICS NOS and ALPHA-AMYLASE SWINE PANCREAS, CELLULASE, LIPASE, PROTEASE NOS (DIGESTIVE ENZYME) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (a swollen lower lip), LIP DISCOLOURATION (White color), SWELLING FACE (The swelling went down under the chin), LIP DISORDER (bumpy), LIP SWELLING (swollen flesh below the lower lip) and SALIVARY HYPERSECRETION (spills some liquid on the side while she talks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include PreserVision Eye Vitamin.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up information received on 10-Jul-2021 contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Head discomfort, Headache
Clinical narrative: my head still feels a little strange; got sick at 3am; soreness at the arm; so weak she could not get out of bed; a little dizzy in the head; could hardly work without help; pain at the injection site; slight fever; headache; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick at 3am), PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head) and HEAD DISCOMFORT (my head still feels a little strange) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the patient.  Concomitant products included CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CLOBETASOL for an unknown indication.    On 22-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued). On 23-Jan-2021 at 3:00 AM, the patient experienced ILLNESS (got sick at 3am). On 25-Jan-2021, the patient experienced HEAD DISCOMFORT (my head still feels a little strange). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 25-Jan-2021, PAIN IN EXTREMITY (soreness at the arm) had resolved. At the time of the report, ILLNESS (got sick at 3am), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), HEAD DISCOMFORT (my head still feels a little strange), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021 did not contain any new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: my head still feels a little strange; got sick at 3am; soreness at the arm; so weak she could not get out of bed; a little dizzy in the head; could hardly work without help; pain at the injection site; slight fever; headache; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick at 3am), PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head) and HEAD DISCOMFORT (my head still feels a little strange) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the patient.  Concomitant products included CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CLOBETASOL for an unknown indication.    On 22-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued). On 23-Jan-2021 at 3:00 AM, the patient experienced ILLNESS (got sick at 3am). On 25-Jan-2021, the patient experienced HEAD DISCOMFORT (my head still feels a little strange). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 25-Jan-2021, PAIN IN EXTREMITY (soreness at the arm) had resolved. At the time of the report, ILLNESS (got sick at 3am), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), HEAD DISCOMFORT (my head still feels a little strange), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021 did not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-may-2021 contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Rash
Clinical narrative: getting second shot >35 days; Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Jan-2021, the patient was diagnosed with PRURITUS (Itchy) and RASH (Rash). On an unknown date, the patient was diagnosed with INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchy), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (getting second shot >35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up received on 03-jun-2021,event was updated, treatment updated
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain after exercise; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain after exercise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no reported medical history).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced BACK PAIN (lower back pain after exercise). At the time of the report, BACK PAIN (lower back pain after exercise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Consumer declined further follow up.