chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Obesity
Clinical narrative: obesity; Poor quality Sleep; Injection site worsening with swelling and induration; Injection site worsening with swelling and induration; Injection site pain; Headache; Fatigue; Myalgias; Left knee pain/pain on any movement mostly joint lines; This spontaneous case was reported by a health care professional and describes the occurrence of OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration) and VACCINATION SITE PAIN (Injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL VALERATE for Menopause.   On 22-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines). On an unknown date, the patient experienced OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias). On 31-Mar-2021, ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines) had resolved. At the time of the report, OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias) 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.   Concomitant product use was not provided by the reporter.  Treatment information included ice and topical pain relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-058239 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058239:First dose case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: obesity; Poor quality Sleep; Injection site worsening with swelling and induration; Injection site worsening with swelling and induration; Injection site pain; Headache; Fatigue; Myalgias; Left knee pain/pain on any movement mostly joint lines; This spontaneous case was reported by a health care professional and describes the occurrence of OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration) and VACCINATION SITE PAIN (Injection site pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESTRADIOL VALERATE for Menopause.   On 22-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines). On an unknown date, the patient experienced OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias). On 31-Mar-2021, ARTHRALGIA (Left knee pain/pain on any movement mostly joint lines) had resolved. At the time of the report, OBESITY (obesity), POOR QUALITY SLEEP (Poor quality Sleep), VACCINATION SITE INDURATION (Injection site worsening with swelling and induration), VACCINATION SITE SWELLING (Injection site worsening with swelling and induration), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Myalgias) 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.   Concomitant product use was not provided by the reporter.  Treatment information included ice and topical pain relief.   This case was linked to US-MODERNATX, INC.-MOD-2021-058239 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: ADR added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058239:First dose case
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Muscle pain). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her body) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRURITUS (Itching all over her body). At the time of the report, PRURITUS (Itching all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications provided. No relevant treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia, Rash
Clinical narrative: It is now on her shoulder; the rash is hot; fever, around 99.5 ° F; rash under her breasts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F), RASH (rash under her breasts) and RASH (It is now on her shoulder) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included Liptore for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F) and RASH (rash under her breasts). On 25-Mar-2021, the patient experienced RASH (It is now on her shoulder). At the time of the report, FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F), RASH (rash under her breasts) and RASH (It is now on her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included liptore. Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            This case was linked to MOD-2021-044803, MOD-2021-044803 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Sore Arm; slight rash on the arm/rash from his knees down; This spontaneous case was reported by a consumer and describes the occurrence of RASH (slight rash on the arm/rash from his knees down) and MYALGIA (Sore Arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (slight rash on the arm/rash from his knees down). On an unknown date, the patient experienced MYALGIA (Sore Arm). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (slight rash on the arm/rash from his knees down) and MYALGIA (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter  Treatment medication includes Anti histamines   This case was linked to MOD-2021-045039 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: Updated reporter address details and event information "rash from his knees down".
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Rash
Clinical narrative: Fever; Chills; Muscle pain; Daughter broke out rash form head to toe; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and RASH (Daughter broke out rash form head to toe) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and RASH (Daughter broke out rash form head to toe). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain) and RASH (Daughter broke out rash form head to toe) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-059071 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059071:Crosslinked with Daughter husband case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 011l20a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full term birth), Pregnancy (1 pregnancy did not reach completion) and Alcohol use. Concurrent medical conditions included Breech presentation (Currently in breech position). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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 an unknown date and the estimated date of delivery was 19-Apr-2021. On 09-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The cesarean delivery occurred on 15-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 3940 grams (8lbs 11oz). The outcome was reported as Delivered NOS. Breech at 36 weeks, version procedure successfully performed at 37 weeks breech again at 38 weeks C-Section Scheduled at Successful at 39 weeks. Head Circumference 36cm. length 55cm. On 09-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive.         Patient stated infant had elevated bilirubin levels but still within normal range (7mg).  Pediatrician believed it's breast milk jaundice but recommended continuing breast feeding.  No treatment information reported.     Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Followup received on 18-MAY-2021contains reporter's address, updated patient's medical history, updated pregnancy outcome details, delivery notes and  infant details.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Ocular discomfort, Palate injury
Clinical narrative: Eyes are feeling very hot; Palate disorder; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (Tired). On 24-Mar-2021, the patient experienced OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache). At the time of the report, FATIGUE (Tired), OCULAR DISCOMFORT (Eyes are feeling very hot), PALATE INJURY (Palate disorder) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.   Concomitant product use was not provided by the reporter.   Treatment medication was provided as Paracetamol.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient had an achy arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 016M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included POTASSIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 ml. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose). At the time of the report, PAIN IN EXTREMITY (Patient had an achy arm after receiving 2nd dose) outcome was unknown.            The patient was given Eye drops for dry eyes as concomitant medication. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity
Clinical narrative: soreness.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (soreness.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (soreness.). At the time of the report, INJECTION SITE HYPERSENSITIVITY (soreness.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: General aches; Intense headache; Chills in spine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (General aches), CHILLS (Chills in spine) and HEADACHE (Intense headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020 and Fracture.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Chills in spine). On 25-Mar-2021, the patient experienced PAIN (General aches) and HEADACHE (Intense headache). On 25-Mar-2021, CHILLS (Chills in spine) had resolved. At the time of the report, PAIN (General aches) and HEADACHE (Intense headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was an oncological chronical patient. Her physician reported that her immunoglobulins where high so he suspended the oncological treatment. No concomitant medications are provided by the reporter. Treatment to the events are provided as 2 Painkillers for the night aches.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up information includes reporter address.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Pressure in head; Body ache; Could not sleep; flu-like symptoms; sore arm; Hotness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Hotness), HEAD DISCOMFORT (Pressure in head), PAIN (Body ache) and SLEEP DISORDER (Could not sleep) in a 60-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.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (Hotness), PAIN (Body ache), SLEEP DISORDER (Could not sleep) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On an unknown date, the patient experienced HEAD DISCOMFORT (Pressure in head). On 19-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. On 21-Mar-2021, FEELING HOT (Hotness), PAIN (Body ache), SLEEP DISORDER (Could not sleep) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. At the time of the report, HEAD DISCOMFORT (Pressure in head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       On 18Mar2021 patient experienced sore arm, and hotness and pressure in the head at night. Reported mentioned body aches so bad patient could not sleep. Symptoms were flu-like. Patient took paracetamol to treat symptoms   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057960:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Pressure in head; Body ache; Could not sleep; flu-like symptoms; sore arm; Hotness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Hotness), HEAD DISCOMFORT (Pressure in head), PAIN (Body ache) and SLEEP DISORDER (Could not sleep) in a 60-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.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FEELING HOT (Hotness), PAIN (Body ache), SLEEP DISORDER (Could not sleep) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On an unknown date, the patient experienced HEAD DISCOMFORT (Pressure in head). On 19-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. On 21-Mar-2021, FEELING HOT (Hotness), PAIN (Body ache), SLEEP DISORDER (Could not sleep) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown. At the time of the report, HEAD DISCOMFORT (Pressure in head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       On 18Mar2021 patient experienced sore arm, and hotness and pressure in the head at night. Reported mentioned body aches so bad patient could not sleep. Symptoms were flu-like. Patient took paracetamol to treat symptoms   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057960:
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue
Clinical narrative: body feels heavy; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body feels heavy) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (body feels heavy) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (body feels heavy) and FATIGUE (fatigue) had resolved.            Concomitant medications include unspecified statin and vitamin medication.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event outcomes and duration updated.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Covid arm; Hives all over chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back). At the time of the report, VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE URTICARIA (Hives all over chest and back) outcome was unknown. Not Provided          No concomitant medication were reported. No Treatment information was provided .
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Headache, Injection site pain, Pyrexia
Clinical narrative: Pregnant patient; Fever; Chills; Headache; Pain at injection site; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 23-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient) outcome was unknown and PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (Pain at injection site) was resolving.            No concomitant medicines were reported.  Action taken with the drug in response to events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: shivering; fatigue; injection site soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 immunization.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness). On 10-Mar-2021, CHILLS (shivering), FATIGUE (fatigue) and INJECTION SITE PAIN (injection site soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:013L20A)via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient received their second of two planned doses of mRNA-1273(Batch number:016M20A) for prophylaxis of COVID-19 infection.  After the first dose of vaccination, the patient experienced headache.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  The outcome of event headache was unknown.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Inhibitory drug interaction
Clinical narrative: Lightheadedness; immune system did not respond to her anxiety and depression medicine; This spontaneous case was reported by a consumer and describes the occurrence of INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine) and DIZZINESS (Lightheadedness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Depression. Concomitant products included SERTRALINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine). On an unknown date, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-045940, MOD-2021-045940 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 045A214A) for an unknown indication.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 1st dose of Moderna COVID Vaccine on 27Jan2021/ received 2nd dose of Moderna COVID Vaccine today) had resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient was given the first dose of Moderna vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications No treatment related information has been reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 006B21A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Tinnitus
Clinical narrative: Tinnitus; Dizziness; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy). At the time of the report, TINNITUS (Tinnitus), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006n20a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and TIMOLOL for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. On 11-Feb-2021, PAIN IN EXTREMITY (Soreness of arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included supplements and timolol in form of eye drops for unknown indication.  On 10 Mar 2021, the patient their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. Action taken was not applicable as the patient received both scheduled doses of vaccine.   This case was linked to MOD-2021-049367 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Heart rate increased, Injection site rash, Pyrexia
Clinical narrative: heart beat went up a little bit; temperature of 105°F; fatigued; 5in long 3in across rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beat went up a little bit), PYREXIA (temperature of 105°F), FATIGUE (fatigued) and INJECTION SITE RASH (5in long 3in across rash on the injection 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 HEART RATE INCREASED (heart beat went up a little bit), PYREXIA (temperature of 105°F), FATIGUE (fatigued) and INJECTION SITE RASH (5in long 3in across rash on the injection arm). At the time of the report, HEART RATE INCREASED (heart beat went up a little bit), PYREXIA (temperature of 105°F), FATIGUE (fatigued) and INJECTION SITE RASH (5in long 3in across rash on the injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 degree f (Inconclusive) 105 Degree F.         No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   This case was linked to US-MODERNATX, INC.-MOD-2021-035080 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035080:dose 1
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphoedema
Clinical narrative: Lymphoedema; Swollen lymph nodes; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LYMPHOEDEMA (Lymphoedema) and LYMPHADENOPATHY (Swollen lymph nodes) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Blood pressure high, Heart disorder, Overweight, Osteoporosis and Arthritis.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). In February 2021, the patient experienced LYMPHOEDEMA (Lymphoedema). At the time of the report, LYMPHOEDEMA (Lymphoedema) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No information regarding corrective treatment was reported by the patient. Caller wanted to report this for her mother, and wanted to know if the lymphoedema will persist, if she is going to be able to walk again, or if this will pass.   This case was linked to MOD-2021-034007 (E2B Linked Report).; Sender's Comments:  MOD-2021-034007:First dose
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had pain for 24 hours on his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had pain for 24 hours on his arm). At the time of the report, PAIN IN EXTREMITY (had pain for 24 hours on his arm) outcome was unknown.            No concomitant product information was reported.  No treatment product information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-045043 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: right arm rosy in color after second dose; right arm hurt after second dose/right arm still sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (right arm rosy in color after second dose) and VACCINATION SITE PAIN (right arm hurt after second dose/right arm still sore to the touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (right arm rosy in color after second dose) and VACCINATION SITE PAIN (right arm hurt after second dose/right arm still sore to the touch). At the time of the report, VACCINATION SITE DISCOLOURATION (right arm rosy in color after second dose) outcome was unknown and VACCINATION SITE PAIN (right arm hurt after second dose/right arm still sore to the touch) had not resolved.            No concomitant medications were reported. Patient was due to go in for endoscopy and colonoscopy on Wednesday and wanted to make sure this was ok since she got the second dose. Patient also was scheduled for a COVID test on Monday and wanted to know if the shot would affect that. She is having her great grandson for the weekend and wanted to make sure he would not be affected. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-035292 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: While receiving vaccine some came out of shoulder; vaccinator re administered the amount they thought came out; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out). On 24-Mar-2021, DEVICE CONNECTION ISSUE (While receiving vaccine some came out of shoulder) and UNDERDOSE (vaccinator re administered the amount they thought came out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Device connection issue and underdose for mRNA-1273, lot # 037a21b,  with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness of left arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (little soreness of left arm). At the time of the report, VACCINATION SITE PAIN (little soreness of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was taken for arm complaints. Concomitant medication included cholesterol medication.   This case was linked to MOD-2021-044454 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: blood sugar started creeping up again; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (blood sugar started creeping up again) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERGLYCAEMIA (blood sugar started creeping up again). At the time of the report, HYPERGLYCAEMIA (blood sugar started creeping up again) outcome was unknown.            No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-035936 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash in the face 3 weeks after each dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in the face 3 weeks after each dose of moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 RASH (rash in the face 3 weeks after each dose of moderna vaccine). At the time of the report, RASH (rash in the face 3 weeks after each dose of moderna vaccine) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 012L20A and 010M20A) for COVID-19 vaccination. No medical history reported. On Jan 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 30, 2021, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. No concomitant medication or treatment information reported.